Full opinion text
ORDER RE: DEFENDANTS’ MOTIONS TO DISMISS FIRST AMENDED COMPLAINT . COLLINS, District Judge. Defendants’ motions to dismiss Plaintiffs First Amended Complaint came on regularly for hearing before this Court on July 15, 1996. After reviewing the materials submitted by the parties, argument of counsel, and the case file, it is hereby ORDERED that Defendants’ motions are GRANTED in part and DENIED in part. I. Procedural Background On September 28,1995, Plaintiff SUMMIT TECHNOLOGY, INC. (“Summit”) filed a Complaint against Defendants HIGH-LINE MEDICAL INSTRUMENTS COMPANY, INC., d/b/a HI-LINE MEDICAL (“Hi-Line”), KENNETH K. YORK AND YORK LASER EYE CENTER (‘Work” Defendants), WILLIAM ELLIS AND EYE CENTER OF NORTHERN CALIFORNIA, INC. (“Ellis” Defendants), and PARIS E. ROYO, PARIS E. ROYO, INC. and ROYO EYE CENTER MEDICAL GROUP (“Royo” Defendants). Summit asserts that Defendants have unlawfully imported, advertised, promoted, used, or serviced Summit Excimer Laser Systems (used to correct a variety of vision disorders) which, according to Summit, have not been approved by the United States Food and Drug Administration (“FDA”). The original Complaint asserted causes of action for false and misleading advertising under § 43(a) of the Lanham Act (15 U.S.C. § 1125(a)), importation of goods bearing infringing marks or names (15 U.S.C. § 1124), infringement of a registered trademark (15 U.S.C. § 1114), copyright infringement, unfair competition in violation of Cal.Bus. & Prof.Code § 17200, common law unfair competition, false and misleading statements in violation of Cal.Bus. & Prof. Code § 17500, and violation of the Sherman Food, Drug, and Cosmetic Act (Cal. Health & Safety Code §§ 26000-26851). On February 28,1996, the Court dismissed Summit’s original Complaint in its entirety. See Order (dated February 28, 1996); Summit Technology, Inc. v. High-Line Medical Instruments Company, Inc., 922 F.Supp. 299 (C.D.Cal.1996). For the most part, this dismissal was with prejudice and without leave to amend. However, the Court dismissed Plaintiff’s false and misleading advertising claims (Lanham Act § 43(a) and Cal.Bus. & Prof.Code § 17500) and its California unfair competition claims without prejudice and with leave to amend. On April 5, 1996, Plaintiff filed a First Amended and Supplemental Complaint (“FASC”) against Defendants Hi-Line, York and Ellis. In the FASC, Plaintiff asserts causes of action for violations of 15 U.S.C. § 1125(a), unfair competition in violation of Cal.Bus. & Prof.Code §§ 17200 et seq., common law unfair competition, and violations of Cal.Bus. & Prof.Code §§ 17500 et seq. The substance of these allegations will be discussed in further detail below. In addition, Plaintiff initially asserted causes of action against York and Ellis for violation of 15 U.S.C. § 1124 and copyright infringement. On April 24, 1996, the parties stipulated to dismiss these last two claims against York and Ellis because they would be directly subject to the Court’s February 28, 1996 Order. On May 15, 1996, Defendants filed separate motions to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). On June 17,1996, Plaintiff filed a consolidated Opposition to Defendants’ motions. Defendants filed separate Reply briefs on July 1, 1996. II. Plaintiff's Allegations In the FASC, Plaintiff realleges the underlying facts alleged in the original Complaint. In its prior Order, the Court discussed these allegations in great detail. See Summit, 922 F.Supp. at 302-04. Accordingly, there is no reason to repeat that discussion in large part. Nevertheless, some repetition will be required in order to fully describe the First Amended and Supplemental Complaint. As discussed in the prior Order, Summit is a Massachusetts corporation that develops, manufactures, sells, and services ophthalmo-logical laser systems for treatment of a variety of eye disorders. FASC ¶¶ 10,16-18. It holds a registered trademark in the name “Summit Technology.” FASC ¶21. In the past decade, Summit has manufactured and sold its “Excimer” laser systems for use abroad and in the United States. FASC ¶ 31. Some of these products were manufactured at domestic Summit facilities and some were manufactured at a Summit facility in Ireland. FASC ¶ 35. On March 10, 1995 and October 20, 1995, Summit received FDA approval for the commercial use of two Excimer systems, the ExciMed UV 200LA (domestic) and SVS Apex (domestic) Systems, to perform Pho-totherapeutie Keratectomy (“PTK”) and Pho-torefractive Keratectomy (“PRK”) under limited circumstances. FASC ¶¶ 32-33. Prior to FDA approval, Summit marketed its Ex-eimer systems in approximately 45 foreign countries, including Canada, Mexico, and several European countries. FASC ¶ 35. Two of the models sold abroad are the ExciMed UV 200LA (international) and the SVS Apex (international) • systems. FASC ¶ 36. According to Plaintiff, these systems differ materially from their domestic counterparts. FASC ¶ 36. The core allegation in Plaintiffs First Amended and Supplemental Complaint is that Defendants have acquired, sold, or used international models of the Excimer systems in the United States. More specifically, Plaintiff alleges that Defendant Hi-Line has “acquired, imported, reimported or facilitated the importation or reimportation into the United States for distribution in the United States” used Summit Excimer systems. FASC ¶48. Summit also alleges that Hi-Line may have acted as a broker, arranging or facilitating the sale of the used international Summit systems. FASC ¶48. According to the FASC, Hi-Line has also advertised and promoted the availability of Summit Excimer systems in sales catalogs, brochures, and at conventions orally. FASC ¶49. In these advertisements, Hi-Line has allegedly made numerous false or misleading statements about the Summit systems. FASC ¶ 50. The specifics of the statements will be discussed in further detail below. According to Plaintiff, the statements allegedly convey the false impression that Summit is affiliated with or approves of Hi-Line’s actions, and that there is no difference between the international Excimer laser system models and the domestic models. FASC ¶ 50. Furthermore, Plaintiff alleges that Hi-Line’s statements convey the impression that the used Hi-Line models can be maintained, installed, serviced and tested by Hi-Line in a manner that makes the machines safe and reliable. FASC ¶ 50. According to Summit, Hi-Line’s allegedly false or misleading statements are likely to cause public confusion and threaten to harm Summit in a variety of ways. FASC ¶ 55-56. Plaintiff alleges that Defendant Ellis purchased a Summit ExeiMed UV 200LA (international) in Canada in August 1994 and then imported it into the United States. FASC ¶ 58. The laser machine purchased by Ellis bears a label stating: “CAUTION [ — ] Inves-tigational Device; Limited by Federal Law to Investigational Use.” FASC ¶ 58. Similar restrictions also appear in the manual accompanying the machine. FASC ¶ 58. According to Plaintiff, prior to purchasing the laser, Ellis sought and received an opinion from counsel, stating that Ellis could lawfully import the device only if it were “solely for use and experimentation upon animals.” FASC ¶ 59. And, in order to pass the machine through U.S. Customs, counsel advised Ellis that the machine had to be “clearly labelled” to exclude the possibility that the machine would be used upon humans. FASC ¶ 59. Ellis allegedly followed this advice and directed his customs broker to indicate that the laser system was for “non-human use.” FASC ¶60. After the successful importation, Ellis also allegedly told an FDA representative (who was visiting Ellis’ office) that the “Excimer laser will be used for animal research ... only.” FASC ¶ 61. According to Plaintiff, Ellis, in fact, “fully intended” to use the imported device on humans. FASC ¶ 62. Moreover, according to Plaintiff, Ellis has never conducted a single animal study with the laser system. FASC ¶ 62. However, Ellis allegedly has performed, continues to perform, and offers to perform various surgical procedures (including PRK and Laser Intrastromal Keratomi-leusis (“LASIK”)) with his imported Summit Excimer laser, although the FDA allegedly has not approved the use of his system for these procedures. FASC ¶ 63. In addition, Ellis has allegedly made a variety of false and misleading statements, by means of writings, advertisements, radio, television, and video. FASC ¶ 64. The specific details of the statements will be discussed below. According to Plaintiff, these statements imply: (1) that the ExeiMed UV 200LA (international) possessed by Ellis is the same as the Summit device sold domestically by Summit; (2) that the Ellis system has been properly serviced and tested; (3) that the Ellis system has been approved by the FDA; (4) that the Ellis system is a new laser. FASC ¶ 64. Ellis’ allegedly false or misleading statements are likely to cause confusion in the public, and threaten to harm Summit in a variety of ways. FASC ¶ 82-83. According to Plaintiff, Defendant York has acquired two used Summit Excimer systems. FASC ¶ 84. York allegedly acquired one of the machines, a Summit Excimed UV 200LA, from Defendant Hi-Line. According to Plaintiff, this machine was originally sold to a person outside the United States under an agreement that barred any sale or shipment into the United States. FASC ¶ 85. In addition, according .to Plaintiff, when sold by Summit, the machine had a label stating: “Investigational Device in Canada. To be used by qualified investigators only.” FASC ¶85. York was allegedly aware that the machine was for Canadian investigational use when he purchased the used machine. FASC ¶ 86. York’s other laser is allegedly either also an ExciMed UV 200LA (international) or a Summit SVS Apex (international), manufactured outside the United States and sold pursuant to similar restrictions detailed above. FASC ¶ 86. In April 1995, York allegedly began commercial use of the Excimed UV 200LA (international) laser on humans. FASC ¶ 87. Using this imported used machine, York has allegedly performed and continues to perform various surgical procedures, including PTK, PRK, and LASIK, despite the alleged lack of FDA approval. FASC ¶88. York allegedly knew that neither machine had received FDA approval at the time he purchased the machines. FASC ¶ 89. On January 27, 1995 and February 24, 1995 York signed documents stating that he was aware that the FDA had not approved the Summit laser machines for PTK and PRK, and that he has not and will not use the machines on humans, except in full compliance with the United States Food, Drug, & Cosmetic Act (“FDCA”). FASC ¶¶ 90-91 and Exhibits 31 and 32 (attached to the FASC). However, in a letter to Hi-Line dated April 6, 1995, York allegedly complained that the ExciMed UV 200LA (international) was non-operational because of lack of parts and servicing, and because of this, York was losing business on PTK and PRK surgery. FASC ¶ 93 and Exhibit 33 (attached to the FASC). According to Plaintiff, York has allegedly attempted to avoid FDA prohibition on York’s use of the reimported Summit system by modifying the laser and claiming the machine is a “custom” device. FASC ¶ 95. Further, York has allegedly promoted and advertised his used Summit machines by making false or misleading oral and written statements. FASC ¶ 96. The specific details of these statements will be discussed below. Plaintiff alleges that these statements, convey the impression that York has a “custom” laser (as opposed to used Summit lasers) that is safe, properly installed and maintained, and has been approved by the FDA. FASC ¶96. The allegedly false or misleading statements are likely to confuse the public and harm Summit in a variety of ways. FASC ¶¶ 101-02. The FDA has sent warning letters to each of the Defendants. On April 28, 1995, the FDA sent a warning letter to Hi-Line, stating that foreign model Summit Excimer Laser Systems could not be sold or imported into the United States. FASC ¶ 41 and Exhibit 7 (attached to the FASC). On May 22, 1995, Hi-Line responded to the FDA letter, essentially denying that Hi-Line’s conduct had violated the FDCA or FDA regulations, and stating that the Hi-Line models were the same as those Summit models approved by the FDA. See Exhibit 8 (attached to the FASC). On August 1, 1995, the FDA responded to the May 22, 1996 letter and adhered to its position. FASC ¶ 42 and Exhibit 9 (attached to the FASC). On November 8, 1995, the FDA further stated that Hi-Line was violating the law and the Hi-Line machines were subject to seizure. FASC ¶ 42 and Exhibit 10 (attached to the FASC). On August 11, 1995, the FDA sent a similar warning letter to Ellis. FASC ¶ 43 and Exhibit 11 (attached to the FASC). The FDA confirmed its position on November 8, 1995, warning Ellis that his machine was subject to seizure. FASC ¶ 44 and Exhibit 10 (attached to the FASC). On April 26, 1995, the FDA sent a similar warning letter to Defendant York, warning York that his machines were not approved by the FDA and were “adulterated and misbranded,” and did not meet the definition of a “custom” device. FASC ¶45 and Exhibit 13 (attached to the FASC). The FDA confirmed this position on August 1, 1995 and November 8, 1995. FASC ¶ 46 and Exhibits 15 and 16 (attached to the FASC). On February 23, 1996, the U.S. Customs Service issued an “Import Alert,” stating that Hi-Line had been importing Summit machines intended for export and not for the U.S. market. FASC ¶ 47 and Exhibit 17 (attached to the FASC). The “Import Alert” also states that Summit machines sold abroad but not intended for domestic use should be detained at the border without physical examination. Id. In sum, Plaintiff alleges that Defendants have made false and misleading statements intended to deceive the public as to the origin and affiliation of the reimported Summit machines. In addition, Plaintiff alleges that Defendants’ statements misrepresent the nature, characteristics, or qualities of their goods, services or commercial activities, in violation of 15 U.S.C. § 1125(a). Further, Plaintiff alleges that Defendants have engaged in unfair competition, in violation of CaLBus. & Prof.Code §§ 17200 et seq. and the common law. Finally, Plaintiff asserts that Defendants have engaged in false or misleading, advertising, in violation of Cal. Bus. & Prof.Code §§ 17500 et seq. Plaintiff seeks injunctive relief, damages, attorneys’ fees, recovery of profits, and costs. III. Discussion A. Standard for Motion to Dismiss for Failure to State a Claim A Rule 12(b)(6) motion tests the legal sufficiency of the claims asserted in the complaint. Rule 12(b)(6) must be read in conjunction with Rule 8(a) which requires “a short and plain statement of the claim showing that the pleader is entitled to relief.” 5A Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 1356 (1990). A Rule 12(b)(6) dismissal is- proper only where there is either a “lack of a cognizable legal theory” or “the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988). A court must accept as true all material allegations in the complaint, as well as reasonable inferences to be drawn from them. NL Industries, Inc. v. Kaplan, 792 F.2d 896, 898 (9th Cir.1986); see also Russell v. Landrieu, 621 F.2d 1037, 1039 (9th Cir.1980) (finding that the complaint must be read in the light most favorable to the plaintiff). However, a court need not accept as true unreasonable inferences, unwarranted deductions of fact, or conclusory legal allegations cast in the form of factual allegations. Western Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir.), cert. denied, 454 U.S. 1031, 102 S.Ct. 567, 70 L.Ed.2d 474 (1981); Hiland Dairy, Inc. v. Kroger Co., 402 F.2d 968, 973. (8th Cir.1968), cert. denied, 395 U.S. 961, 89 S.Ct. 2096, 23 L.Ed.2d 748 (1969). Furthermore, unless a court converts a Rule 12(b)(6) motion into a motion for summary judgment, a court cannot consider material outside of the complaint (e.g., facts presented in briefs, affidavits, or discovery materials). Levine v. Diamanthuset, Inc., 950 F.2d 1478, 1483 (9th Cir.1991), overruled on other grounds by Central Bank of Denver, N.A. v. First Interstate Bank of Denver, N.A, et al., 511 U.S. 164, 114 S.Ct. 1439, 128 L.Ed.2d 119 (1994). A court may, however, consider exhibits submitted with the complaint and matters that may be judicially noticed pursuant to Federal Rule of Evidence 201. Hal Roach Studios, Inc. v. Richard Feiner & Co., 896 F.2d 1542, 1555 n. 19 (9th Cir.1989); Mack v. South Bay Beer Distributors, Inc., 798 F.2d 1279 (9th Cir.1986), abrogated on other grounds by Astoria Federal Savings and Loan Ass’n v. Solimino, 501 U.S. 104, 111 S.Ct. 2166, 115 L.Ed.2d 96 (1991). Lastly, a Rule 12(b)(6) motion “will not be granted merely because [a] plaintiff requests a remedy to which he or she is not entitled.” Schwarzer, et al., Civil Procedure Before Trial § 9:230. “It need not appear that plaintiff can obtain the specific relief demanded as long as the court can ascertain from the face of the complaint that some relief can be granted.” Doe v. United States Dept. of Justice., 753 F.2d 1092, 1104 (D.C.Cir.1985); see also Doss v. South Central Bell Telephone Co., 834 F.2d 421, 425 (5th Cir.1987) (demand for improper remedy not fatal if claim shows plaintiff entitled to different form of relief). B. Analysis As stated above, on February 28,1996, the Court dismissed Plaintiff’s original Complaint in its entirety. In its First Amended and Supplemental Complaint, Plaintiff focuses its case on Defendants’ allegedly false and misleading statements, as well as Defendants’ allegedly unfair competition. Because each Defendant made separate statements, engaged in separate conduct, and each Defendant has filed a separate motion, the Court will address Plaintiffs allegations against each Defendant separately within the context of each cause of action. 1. Plaintiff’s First Claim for Relief Under § 43(a) of the Lanham Act In relevant part, § 43(a) of the Lanham Act states as follows: Any person who, on or in connection with any goods or services ... uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any false designation of origin, false or misleading description of fact, or false or misleading representation of fact, which — (A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin-, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or (B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damaged by such act. 11 U.S.C. § 1125(a). As indicated by the statute, there are essentially two general categories of § 43(a) violations — trademark infringement/false designation of origin (15 U.S.C. § 1125(a)(1)(A) and false advertising (§ 1125(a)(1)(B))). Summit asserts both theories against all three Defendants. In order to succeed on an infringement/false designation of origin claim under § 1125(a)(1)(A), Plaintiff must prove each of the following elements: (1) defendant uses a designation (any word, term, name, device, or any combination thereof) or false designation of origin; (2) the use was in interstate commerce; (3) the use was in connection with goods or services; (4) the designation or false designation is likely to cause confusion, mistake, or deception as to (a) the affiliation, connection, or association of defendant with another person, or (b) as to the origin, sponsorship, or approval of defendant’s goods, services, or commercial activities by another person; and (5) plaintiff has been or is likely to be damaged by these acts. 3 J. Thomas McCarthy, McCarthy on Trademarks and Unfair Competition § 27.03[l][a]. “A likelihood of confusion exists when consumers ‘are likely to assume that a product or service is associated with a source other than its actual source because of similarities between the two sources’ marks or marketing techniques.’ ” Metro Publishing, Ltd. v. San Jose Mercury News, 987 F.2d 637, 640 (9th Cir.1993) (quoting Nutri/System, Inc. v. Con-Stan Indus., Inc., 809 F.2d 601, 604 (9th Cir.1987) and Shakey’s Inc. v. Covalt, 704 F.2d 426, 431 (9th Cir.1983)). Further, the Ninth Circuit has identified six basic factors critical to a court’s inquiry into likelihood of confusion: (1) the strength of the plaintiffs mark; (2) the similarity of the marks; (3) evidence of actual confusion; (4) marketing channels used; (5) type of goods and degree of care likely to be exercised by the purchaser of the goods; and (6) defendant’s intent in selecting the mark. Americana Trading, Inc. v. Russ Berrie & Co., 966 F.2d 1284, 1287 (9th Cir.1992). In order to make out a false advertising claim under § 1125(a)(1)(B), Plaintiff must prove the following five basic elements: (1) in its ... advertisements, defendant made false statements of fact about its product or the product of another; (2) those advertisements actually deceived or have the tendency to deceive a substantial segment of their audience; (3) the deception is material, in that it is likely to influence the purchasing decision; (4) defendant caused its falsely advertised goods to enter interstate commerce; and (5) plaintiff has been or is likely to be injured as the result of the foregoing either by direct diversion of sales from itself to defendant, or by lessening of the good will which its products enjoy with the buying public. Cook, Perkiss & Liehe v. Northern California Collection Service, Inc., 911 F.2d 242, 244 (9th Cir.1990) (quoting Skil Corp. v. Rockwell Int'l Corp., 375 F.Supp. 777, 783 (N.D.Ill.1974)). a. Hi-Line In the FASC, Plaintiff asserts that, in its written advertisements and orally at conventions, Hi-Line has made statements that convey the following three false impressions: (1) that there is an affiliation or association with, or approval by, Summit, as to Hi-Line’s actions; (2) that there is no difference between the international and domestic models of the Exeimer laser systems at issue in the case; and (3) that the international models that Hi-Line sells may be maintained, installed, serviced, and tested by Hi-Line or another party in a manner that makes them safe and rehable. FASC ¶ 50. The first “false impression” is in fact an attempt to state a claim under § 1125(a)(1)(A), the “false association” prong of § 43(a). The other two “false impressions” are attempts to state claims under § 1125(a)(1)(B), the “false advertising” prong. However, in the FASC, Plaintiff does not draw a fine distinction between the two types of claims. Plaintiff simply refers to Hi-Line’s statements as “false or misleading.” For the purposes of Hi-Line’s motion, the distinction between the statutory provisions is not material (because Hi-Line has not challenged Plaintiffs standing as a competitor). Nevertheless, in the interest of clarity, the Court will follow the statutory scheme in its analysis of Hi-Line’s allegedly false or misleading statements. In the FASC, Plaintiff lists nine “example[s]” of Hi-Line’s allegedly false statements. According to Plaintiff, this list is only illustrative, not “exhaustive.” Plaintiffs Opposition at 19. Summit alleges that Hi-Line has “made many actionable statements orally and in writing in addition to those described[.]” Id. Regardless, the Court will address Plaintiffs “examples” directly for their legal sufficiency. (1) Allegedly False Claims Indicating an Affiliation between Hi-Line’s Activities and Summit (15 U.S.C. § 1125(a)(1)(A)) (a) Hi-Line’s Misstatements Described in FASC ¶ 51(a) In ¶ 51(a) of the FASC, Plaintiff asserts that Hi-Line has orally misrepresented that Hi-Line and Summit have an “agency relationship.” Because the Court must accept Plaintiffs allegations as true, this allegation stands. Additionally, in ¶ 51(a), Plaintiff also alleges that by stating that it “represents only those companies who have established a reputation for quality and fair pricing,” Hi-Line also indicates an agency relationship. See Exhibit 18 (attached to the FASC) (emphasis added). Drawing all reasonable inferences in Plaintiffs favor, the Court agrees. Hi-Line’s statement is within a “Products Catalog” sent to potential customers. Within the catalog is, allegedly, a picture of a Summit machine. Because Summit manufactures some of the used machines Hi-Line sells, the use of the word “represents” gives rise to a reasonable inference of an agency relationship. Because Plaintiff alleges that such an agency relationship does not exist, Plaintiff’s false affiliation claim stands. (b) Hi-Line’s Statements in Invoices Allegedly Implying Some Affiliation with Summit or Some Obligation Summit may have to Third Party Customers In ¶ 51(b) of the FASC, Plaintiff alleges that in certain invoices, Hi-Line has misrepresented or implied some affiliation between Summit and Hi-Line. See FASC ¶ 51(c) and Exhibit 19. For example, in the invoice for Hi-Line’s sale to York, Hi-Line represents the following: (1) Hi-Line warrants the Excimer laser for a specified period of time (2) Hi-Line is ... not responsible for any adverse or unacceptable medical surgical outcomes as a result of the buyers [sic], or others at his/hers [sic] facility's, use of the laser. All such claims should be addressed to the original manufacturer who is responsible for the design and building of the product. (3) It is understood that Hi-Line is strictly an agent for resale, having purchased the laser from an existing user or distributor and reselling it to the buyer. (4) Additional warranties may be purchased from Summit for an additional cost. Exhibit 19 (attached to the FASC). Plaintiff asserts that, taken together, these statements “are false and misleading because they state, or by implication or material omission leave the misimpression, that Summit will provide warranties to Hi-Line’s buyers, is affiliated or associated with, or connected to, Hi-Line and will be responsible for certain third-party claims, when Summit does not and is not.” FASC ¶ 51(b). Giving Plaintiff the benefit of all reasonable inferences, the Court finds that the allegations in ¶ 51(b) are sufficient to state a claim under § 1125(a)(1)(A). First, the invoice directly states that additional warranties may be purchased from Summit. Summit alleges that this is literally false. Second, the use of the words “agent for resale” together with references to Summit gives rise to a reasonable inference that the statement indicates some agency relationship or affiliation and may mislead consumers. Third, Summit asserts that the statement concerning third party liability is literally false. Accordingly, Plaintiff’s allegations in ¶ 51(b) are sufficient to state a claim under § 1125(a)(1)(A). (2) Allegedly False Factual Claims Concerning the Products (15 U.S.C. § 1125(a)(1)(B)) (a) Hi-Line’s Statement that the Imported Summit Systems are “Perfectly Reliable” (FASC ¶ 51(c)) In some of its advertisements, Hi-Line asserts as follows: With more and more companies entering the market with new, more sophisticated systems, a secondary market is forming for older model lasers in good condition. A perfectly reliable used Excimer laser can be purchased for almost half of the current asking price of a new Unit. FASC ¶ 51(e) & Exhibits 18, 20, and 25 (attached to the FASC) (emphasis added). Plaintiff asserts that this statement is false or misleading because it “leaves the misim-pression that ... the Summit lasers offered for sale by Hi-Line are perfectly reliable, when the lack of proper installation, service, testing, parts and gas means they are not rehable.” FASC ¶ 51(c). Defendant Hi-Line asserts that this statement is not actionable under the Lanham Act because it is mere “puffery” or opinion stated in general terms, not a specific statement of fact about the attributes of the product. As such, and as a matter of law, the statement is not a material statement expected to induce reasonable consumer rebanee. See Defendant Hi-Line’s Motion at 15 (citing Cook, 911 F.2d at 246). Puffery is often described as “involving outrageous generalized statements, not making specific claims, that are so exaggerated as to preclude rebanee by consumers.” Cook, 911 F.2d at 246 (citing Metro Mobile CTS, Inc. v. Newvector Communications, Inc., 643 F.Supp. 1289 (D.Ariz.1986), rev’d without opinion, 803 F.2d 724 (9th Cir.1986)). In the FTC context, the Ninth Circuit has also defined “puffery” as “claims [which] are either vague or highly subjective.” Cook, 911 F.2d at 246 (quoting Sterling Drug, Inc. v. Federal Trade Commission, 741 F.2d 1146, 1150 (9th Cir.1984), cert. denied, 470 U.S. 1084, 105 S.Ct. 1843, 85 L.Ed.2d 143 (1985)); see also 3 McCarthy, § 27.04[4][d] (“ ‘Puffing may also consist of a general claim of superiority over a comparative product that is so vague, it wib be understood as a mere expression of opinion.’”). Thus, “advertising which merely states in general terms that one product is superior is not actionable.” Cook, 911 F.2d at 246 (quoting Smith-Victor Corp. v. Sylvania Electric Products, Inc., 242 F.Supp. 302, 308-09 (N.D.Ill.1965)); see also Lipton v. Nature Co., 71 F.3d 464, 474 (2d Cir.1995) (“Subjective claims about products, which cannot be proven either true or false, are not actionable under the Lanham Act”). However, “misde-scriptions of specific or absolute characteristics of a product are actionable.” Cook, 911 F.2d at 246 (quoting Stiffel Co. v. Westwood Lighting Group, 658 F.Supp. 1103, 1115 (D.N.J.1987)). Furthermore, the Ninth Circuit has expressly authorized the use of the 12(b)(6) motion to dismiss to determine whether or not a statement is non-actionable puffery. Cook, 911 F.2d at 245. The Court agrees that Hi-Line’s statement that the used Excimer lasers are “perfectly rebable” is mere puffery, not actionable under the Lanham Act. In stating that the used machines are “perfectly rehable,” Hi-Line clearly does not bteraby mean that the machines are “100% rebable,” which would mean they never break down. Indeed, in bght of the mere existence of Summit technicians, Plaintiff admits that even the new machines are not “100% rebable.” Even the new machines require some service. In the context of the Hi-Line advertisement, “perfectly rebable” is more reasonably a claim that the used machines are as reliable as the new machines—a statement akin to a general claim of product superiority. As such, the phrase is mere puffery. Furthermore, to the extent that “rebable” is meant to convey simply that the machine functions, this is also puffery. The word “rebable” is inherently vague and general— in common parlance akin to a statement that the machine is “fine.” In the context of the entire advertisement, the phrase “perfectly rebable” is not couched in terms that would indicate independent verifiabihty. See, e.g., Stiffel Co. v. Westwood Lighting Group, 658 F.Supp. 1103, 1114-15 (D.N.J.1987) (claims of superiority not puffing when accompanied by statistical results of purportedly independent survey). Rather, it is simply a vague statement that the machines are “rebable,” a claim incapable of objective verification and not expected to induce reasonable consumer rebanee. See, e.g., Thompson Medical Co., Inc. v. Ciba-Geigy Corp., 643 F.Supp. 1190, 1199-1200 (S.D.N.Y.1986) (phrase “Lose Weight Fast” found to be non-actionable puf-fery). Accordingly, to the extent that Plaintiff’s first claim for relief against Hi-Line relies on the statement that the Hi-Line used machines are “perfectly reliable,” it is dismissed. (b) Hi-Line’s Statements Concerning “Service Engineers” In ¶ 51(d) of the FASC, Plaintiff alleges that in certain invoices and orally, Hi-Line states that the used Summit systems “mil be installed by a ‘service engineer’ as arranged by Hi-Line, and that such person ■will ‘show you how to operate it.’ ” FASC ¶ 51(d) and Exhibit 21 (attached to the FASC). In addition, Hi-Line also provides additional servicing through the “service engineer.” Id. Plaintiff contends that these statements are false and misleading “because they state, or by implication or material omission leave the false impression that, a ‘service engineer’ identified by Hi-Line is competent properly to install, maintain, service and test the Summit laser offered for sale by Hi-Line, when this is false.” FASC ¶ 51(d). To the extent that the statements imply that the “service engineers” are “competent,” the Court finds that this is a general matter of opinion, not actionable under the Lanham Act. First of all, within the context of the invoice, “competence” may mean that the Hi-Line “service engineers” are as competent as the Summit engineers. As with “perfectly reliable,” this type of innocuous comparison is mere puffery. Second, if Hi-Line means that the engineers are simply “competent” (not in comparison to the Summit engineers), this is far too vague, subjective, and incapable of verification to be actionable under the Lanham Act. Cook, 911 F.2d at 246. Accordingly, to the extent that Plaintiff’s first claim for relief against Hi-Line relies on statements listed in FASC ¶ 51(d), it must be dismissed. (c) Hi-Line’s Statements that it may Lawfully Import Used Summit Lasers In ¶ 51(e) of the FASC, Summit alleges that on various occasions orally, and in a sales catalog, Hi-Line has represented that it “may lawfully import previously owned Summit lasers.” FASC ¶ 51(e) and Exhibit 22 (attached to the FASC). Plaintiff asserts that this statement is false or misleading “because it states, or by implication or material omission leaves the false impression that, Hi-Line is lawfully entitled to import Summit lasers when it is not and has been so advised by the FDA.” FASC ¶ 51(e). Furthermore, Plaintiff alleges that to the extent that Hi-Line has based the statement on an opinion of counsel, it is misleading because the opinion was formed in response to FDA warning letters stating that such importation was illegal. Hi-Line asserts that this statement is not actionable because it invades the FDA’s exclusive jurisdiction over violations of the FDCA. In its original Complaint, Plaintiff alleged that Defendants violated § 43(a) of the Lan-ham Act by failing to disclose that (1) the used Summit systems are not approved by the FDA; (2) that the used or modified systems are materially different from the FDA-approved systems; (3) that Summit has not serviced the machines and cannot do so under FDA regulations; (4) that proper maintenance and training is of critical importance; and (5) that Defendants cannot provide the required Summit service or training. See Summit, 922 F.Supp. at 305-06. Ultimately, Plaintiffs original allegations all “tum[ed] on whether Defendants have failed to disclose the allegedly illegal status of their re-imported systems, or whether Defendants have failed to disclose that, under FDA regulations, Summit has not been able to maintain the machines or train users.” Summit, 922 F.Supp. at 306. In the prior Order, the Court rejected these allegations, finding them to be impermissible private vehicles for enforcing the FDCA and FDA regulations. Id. at 305-06. As explained in the prior Order, under 21 U.S.C. § 337(a), the FDCA provides that “all such proceedings for the enforcement, or to restrain violations, of [the Act] shall be by and in the name of the United States.” Accordingly, there is no private right of action to enforce the provisions of the FDCA or FDA regulations. See Summit, 922 F.Supp. at 305 (citing Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir.)), cert. denied, — U.S. -, 115 S.Ct. 429, 130 L.Ed.2d 342 (1994) (citing Pacific Trading Co. v. Wilson & Co., Inc., 547 F.2d 367, 370 (7th Cir.1976) and other cases); see also Fender v. Medtronic, Inc., 887 F.Supp. 1326, 1329 (E.D.Cal.1995) (the FDCA “gives the FDA comprehensive regulatory authority over medical devices.”). Following Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir.1993), cert. denied, 510 U.S. 1197, 114 S.Ct. 1307, 127 L.Ed.2d 658 (1994) and Sandoz Pharmaceuticals v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir.1990), the Court found that Plaintiffs Lanham Act § 43(a) claims “strayed too close to the exclusive enforcement domain of the FDA.” Summit, 922 F.Supp. at 306. The Court held that “absent an affirmative misrepresentation that a drug had been officially approved by the FDA, a Lanham Act claim alleging that the defendant had failed to disclose FDA non-approval could not stand.” Summit, 922 F.Supp. at 306. In essence, such a claim would allow a private litigant to interfere with the FDA’s own investigatory time-table and prosecutorial decision-maMng. Furthermore, the claim would force the Court to rule directly “on the legality of Defendants’ conduct before the FDA has had a chance to do so.” Id.; see also id. (“A Lanham Act cause of action cannot stand if it alleges that a defendant has faded to disclose the fact of FDA non-approval, when the FDA has not yet determined whether or not the product in question has been approved.”). In other words, the Lanham Act does not allow a federal court to “determine preemptively how a federal agency will interpret and enforce its own regulations.” Sandoz, 902 F.2d at 231; see also Dial A Car, Inc. v. Transportation, Inc., 82 F.3d 484, 490 (D.C.Cir.1996) (in an analogous case, Lanham Act could not be used as “back-door method” of interpreting and enforcing administrative regulations). However, false statements are actionable under the Lanham Act, even if their truth may be generally within the purview of the FDA. For example, in Mylan, the defendant had allegedly falsely represented that its product was “bioequivalent” to another product and entitled to “AB” rating from the FDA. The plaintiff alleged that the data for the defendant’s bioequivalenee studies was fraudulent. Although FDA regulations do define “bioequivalenee,” the Fourth Circuit allowed the action to proceed because the defendant’s statement of “bioe-quivalenee” was literally false. Mylan, 7 F.3d at 1138. Further, the factual question of “bioequivalenee” was a scientific matter that could be resolved without reference to a particular interpretation of FDA regulations. Similarly, in Grove Fresh Distributors, Inc. v. The Flavor Fresh Foods, Inc., 720 F.Supp. 714, 715 (N.D.Ill.1989), although FDA regulations defined “100% pure orange juice,” the Court could determine the commercial definition of “pure” orange juice without performing an authoritative interpretation and direct application of FDA regulations. See also Energy Four, Inc. v. Dornier Medical Systems, Inc., 765 F.Supp. 724 (N.D.Ga.1991) (Lanham Act claim allowed in case where no need to directly interpret or apply FDA regulations and where party had affirmatively represented FDA approval). By contrast, in Sandoz, the matter in question was solely governed by an interpretation of FDA regulations. The Sandoz plaintiff alleged that the defendant had falsely la-belled an ingredient as “inactive” when FDA standards required the ingredient be labelled as “active.” The Third Circuit found that such an allegation could not stand because it was a direct claim of misbranding, entirely governed by FDA regulations, concerning a subject that the FDA had not yet resolved. The Sandoz court held that “[bjeeause agency decisions are frequently of a discretionary nature or frequently ^require expertise,” the court would not preempt the exercise of that discretion by directly interpreting and applying FDA regulations via a Lanham Act claim. Sandoz, 902 F.2d at 231. Otherwise, the court would be forced to “usurp [the] administrative agenc[y]’s responsibility for interpreting. and enforcing potentially ambiguous regulations.” Id. In its advertising, Hi-Line allegedly states that “[o]ur council [sic] Mr. William Appier has advised that we may import previously owned lasers.” FASC ¶ 51(e) and Exhibit 22. In essence, Hi-Line is affirmatively communicating to its consumers that it believes that the importation of the Summit lasers is legal. Plaintiff asserts this is false. However, in order for this Court to test the truth of Defendant’s apparent claim that it can legally import the Summit lasers, the Court would be required to perform an “original interpretation” of the FDA regulations governing this area. Sandoz, 902 F.2d at 231. In other words, the Court would be required to determine whether Hi-Line is legally importing used Summit lasers under the FDCA and FDA regulations. Under the Sandoz rule and the holding of the prior Order, this the Court cannot do. Simply judging from the correspondence attached as exhibits to the Complaint, it is apparent that the FDA has not yet determined whether to take action against Hi-Line for its importation of used Summit lasers. In essence, the FDA has not yet determined how it will interpret and enforce its own regulations with regard to this question, and the Court must therefore decline to usurp the FDA’s authority. Simply put, the proper interpretation and enforcement of the relevant FDA regulation is not an issue properly decided “as an original matter by a district court in a Lanham Act case.” Sandoz, 902 F.2d at 232. Accordingly, to the extent that Plaintiffs first cause of action against Hi-Line is founded upon the statements in ¶ 51(e), it must be dismissed. (d) Hi-Line’s Alleged Statement that the Summit ExciMed UV 200 LA (international) is Identical to the ExciMed UV 200 LA (domestic) In 151(f) of the FASC, Plaintiff asserts that Hi-Line has made the affirmative representation that the international and domestic versions of the ExciMed UV 200 LA lasers are “identical.” FASC ¶ 51(f) and Exhibit 23. Hi-Line contends that this claim must fail because it invades the exclusive jurisdiction of the FDA. The FDA is currently evaluating the degree to which the international and domestic Summit lasers are similar and whether the international lasers re-imported by Hi-Line require further approval. However, the question of whether the domestic and international lasers are “identical” is a factual one that can be resolved without the interpretation or application of FDA regulations. Accordingly, this Court’s inquiry into whether Hi-Line’s statements are false does not tread on the FDA’s exclusive domain. Therefore, Plaintiffs allegation in FASC ¶ 51(f) that Hi-Line has falsely claimed that the lasers are identical must stand. (e) Hi-Line’s Alleged Statement Concerning a Physician’s Ability to Use the Machine Regardless of FDA Approval Also in ¶ 51(f) of the FASC, Plaintiff asserts that in the same “Patient Informed Consent” form, allegedly distributed by Hi-Line, Defendant states that the FDA “permits a physician to use an approved device such as the ExciMed UV 200 LA ... for any use for which it is capable, whether that indication is approved [by FDA] or not.” FASC ¶ 51(f) and Exhibit 23. Again, Hi-Line contends that this statement is not actionable on a Lanham Act claim because it invades the exclusive jurisdiction of the FDA. The truth or misleading nature of this statement depends on two steps. First, because the Consent Form does not distinguish between the ExciMed UV 200 LA (international) and the ExciMed UV 200 LA (domestic), the Court must determine whether or not they are, in fact, identical. As stated above, this the Court may do. However, the second step creates the problem. Whether the FDA actually permits physicians to use the ExciMed lasers sold by Hi-Line “for any use for which it is capable, whether that indication is approved or not” is an issue requiring a direct interpretation and application of FDA regulations. Because this is a matter for the FDA (in the first instance), and not for a district court on a Lanham Act claim, this allegation cannot stand. Accordingly, to the extent that Plaintiffs first claim for relief against Hi-Line rests on the statement alleged in ¶ 51(f) that. Hi-Line misrepresents the legality of a physician’s use of Hi-Line’s Summit lasers, it must be dismissed. (f) Hi-Line’s Statements in its Press Releases In ¶ 51(g) of the FASC, Plaintiff alleges that Hi-Line has made the following misrepresentations that: given the FDA’s approval of certain Summit Exeimer Laser Systems, buyers in the United States are permitted by the FDA to perform “FDA approved” procedures on the international models of Summit Excimer Laser Systems and that these products can be serviced by Summit or by “HI-LINE MEDICAL designated service personnel.” FASC ¶ 51(g) and Exhibit 24. Plaintiff asserts that these statements are false and misleading because they leave the misim-pression that FDA approval applies to the lasers sold by Hi-Line. The Court agrees. While this is not a bald representation of FDA approval, it comes very close. The November 9, 1994 Press Release (attached to the FASC as Exhibit 24) begins by stating that Hi-Line has “aggressively entered the previously owned Ex-cimer Laser business[.]” Then, in the next sentence, the Release states that “[t]he FDA has granted ‘conditional’ approval to one Ex-cimer laser manufacturer at the FDA Panel Meeting[J” There is no qualification that the Excimer lasers sold by Hi-Line are not covered by this official approval. Without such a qualification, the statement leaves the false impression that the Excimer lasers sold by Hi-Line are “FDA approved,” which is allegedly not true. Unlike the statements alleged in the original Complaint, Hi-Line has not simply placed its used Summit lasers without disclosing nonapproval. As held in the prior Order, such a claim is not actionable under the Lanham Act. Rather, Hi-Line’s Press Release could be construed as an affirmatively misleading statement that the Excimer lasers sold by Hi-Line have, in fact, been approved by the FDA. Such a claim is cognizable under the Lanham Act. Summit, 922 F.Supp. at 306. Accordingly, Plaintiffs allegation under ¶ 51(g) may stand. (g) Hi-Line’s Alleged Statements that the FDA Permits the Domestic Use of Foreign Models of Summit Excimer Laser Systems if They are Serviced by Summit or “Hi-Line Designated Personnel” Although Plaintiff has not given specific examples (except for Exhibit 24—where “Hi-Line Designated Service Personnel” are mentioned), Plaintiff alleges that Hi-Line has stated that the FDA permits the domestic use of foreign Summit models if they are serviced by Summit or “Hi-Line designated personnel.” FASC ¶ 51(h). The question of who may legally repair Summit equipment is clearly a matter requiring the interpretation and application of FDA regulations. Accordingly, Plaintiff may not bring a direct action alleging that Hi-Line violates § 43(a) by asserting that Hi-Line personnel can legally service Summit lasers. Paragraph ¶ 51(h) also contains the allegation that Hi-Line asserts that the FDA “permits” the domestic use of the foreign Summit models. This allegation also may not stand. As stated above, a statement of “FDA approval” is actionable because it is verifiable without reference to FDA regulations. “FDA approval” implies an official regulatory act certifying a product is “approved.” However, Hi-Line’s alleged statement that the FDA “permits” domestic use is far more nebulous and would certainly require interpretation and application of FDA regulations. Accordingly, Plaintiffs allegations under FASC ¶ 51(h) cannot stand. (h) Hi-Line’s Alleged Statement that the FDA Permits the Importation Into, and Commercial Use in, the United States of Foreign Summit Lasers In ¶ 51 (i) of the FASC, Plaintiff alleges that Hi-Line has misrepresented that the FDA permits the “importation into, and commercial use in, the United States of foreign models of Summit Excimer Laser Systems.” For the reasons discussed in sections II.B.l.a.(2)(c) and II.B.l.a.(2)(g), this allegation cannot stand under the Lanham Act. Accordingly, it is dismissed. (i) Hi-Line’s Alleged Statements that Summit Lasers Can Receive Proper Installation, Service, Maintenance, and Testing In ¶ 51(j) of the FASC, Plaintiff contends that Hi-Line has misrepresented that its lasers “have received and can receive proper installation, service, maintenance and testing.” FASC ¶ 51(j). To the extent that this allegation can be interpreted to mean that Hi-Line has misrepresented that it may legally service used Summit machines, it cannot stand. Such an allegation would require an original interpretation and application of FDA regulations, not cognizable under the Lanham Act. To the extent that the allegation can be interpreted to mean that Hi-Line has misrepresented that it may competently service used Summit machines, it cannot stand because such a statement is mere puf-fery (see discussion above). Accordingly, to the extent that Plaintiffs first claim against Hi-Line rests on ¶ 51 (j), it must be dismissed. (3) Unspecified Other Allegations of False Advertising Plaintiff asserts that the allegations discussed above are merely examples, “illustrative, not exhaustive.” Plaintiffs Opposition at 19. Indeed, in ¶ 50, Plaintiff asserts that Hi-Line “has made numerous false or misleading statements about Summit Exci-mer Laser Systems.” Plaintiff further alleges that the statements misleadingly convey the following three basic impressions: (1) that there is an affiliation or association between Summit and Hi-Line’s actions; (2) there is no difference between the international and domestic models; and (3) that the international models Hi-Line sells may be maintained, installed, serviced and tested by Hi-Line in a manner that makes them safe and reliable. FASC ¶ 50. Lastly, in ¶ 51(a), Plaintiff states that the specific allegations are placed “[b]y way of example only[.]” Under Federal Rule of Civil Procedure 8(a), the Court finds these general allegations to be sufficient to give Defendant “fair notice” of Plaintiffs claim. See Leatherman v. Tarrant County Narcotics Intelligence & Coordination Unit, 507 U.S. 163, 165-67, 113 S.Ct. 1160, 1162, 122 L.Ed.2d 517 (1993). Clearly, Rule 8(a) does not require Plaintiff to set forth specific allegations or evidentiary facts. All that is required is a “short and plain statement” of Plaintiffs claim for relief. However, the Court does note that to the extent that Plaintiffs unspecified allegations match or mirror those discussed above, the Court will treat them similarly. (4) Summary with Regard to Hi-Line To recapitulate, with regard to the specific allegations supporting Plaintiffs first cause of action against Hi-Line, the Court makes the following rulings: 1.) Defendant’s motion is DENIED as to: ¶ 51(a) (misstatements re: agency), ¶ 51(b) (misstatements re: agency and affiliation in the invoice), ¶ 51(f) (identical lasers); and ¶ 51(g) (press release statements re: FDA approval); 2.) Defendant’s motion is GRANTED as to: ¶ 51(c) (“perfectly rehable”), ¶ 51(d) (competent service engineers), ¶ 51(e) (lawful importation of previously owned lasers), ¶ 51(f) (statements re: FDA’s rules regarding physician use of approved devices), ¶ 51(h) (FDA permits domestic use if serviced by Summit or Hi-Line personnel), ¶ 51(i) (FDA permits importation), and H51(j) (proper installation and service). To the extent that Plaintiffs first claim for relief against Hi-Line rests on these allegations, it is dismissed; 3.) With regard to the substance of Plaintiffs unspecified allegations described in ¶50, the Court’s order will apply equally to them. b. Ellis In the FASC, Plaintiff asserts that Defendant Ellis has made numerous false or misleading statements concerning the Summit ExciMed UV 200LA (international) that Ellis allegedly possesses. According to Plaintiff, Ellis has stated or implied the following general misrepresentations: (1) that the international and domestic models of the ExciMed UV 200LA are the same; (2) that the Ex-ciMed UV 200LA (international) has been properly serviced and tested; (3) that the ExciMed UV 200LA has been approved by the FDA; and (4) that the ExciMed UV 200LA is a new laser. As with its allegations against Hi-Line, Plaintiff has also listed several “examples” of Ellis’ false or misleading statements. Again, according to Plaintiff, this list is only illustrative, not “exhaustive.” Plaintiff’s Opposition at 19. Nevertheless, the Court will address Plaintiffs “examples” directly for their legal sufficiency. Before turning to the specific allegations, however, the Court must address one threshold matter. Defendant Ellis asserts that under Ninth Circuit law, Summit has no standing to sue Ellis for false advertising because they are not in a competitive relationship, but rather one of purchaser-seller. Ellis contends that while Summit is in the business of manufacturing and selling laser equipment, Ellis is merely a doctor who happens to have purchased a used Summit machine. As stated by Ellis, “Summit is not an ophthalmologist and does not practice ophthalmic medicine in Northern California.” Defendant Ellis’ Motion at 18. “A false advertising claim implicates the Lanham Act’s purpose of preventing unfair competition.” Stanfield v. Osborne Industries, Inc., 52 F.3d 867, 873 (10th Cir.), cert. denied, — U.S. -, 116 S.Ct. 314, 133 L.Ed.2d 217 (1995) (citing 15 U.S.C. § 1127). Thus, in Halicki v. United Artists Communications, Inc., 812 F.2d 1213 (9th Cir.1987), the case primarily relied upon by Ellis, the Ninth Circuit held that § 43(a) of the Lanham Act is confined to remedy “injuries] to a competitor.” Id. at 1214; contra Camel Hair & Cashmere Institute, Inc. v. Associated Dry Goods Corp., 799 F.2d 6, 11 (1st Cir.1986) (“there appears to be a general consensus that the plaintiff does not have to be a competitor in order to have standing to sue” under § 43(a) of the Lanham Act); 3 McCarthy § 27.04[3][e] (calling the Halicki decision an “aberration in the history of court interpretation of § 43(a)”). In Waits v. Frito-Lay, Inc., 978 F.2d 1093 (9th Cir.1992), cert. denied, 506 U.S. 1080, 113 S.Ct. 1047, 122 L.Ed.2d 355 (1993), the Ninth Circuit clarified the Halicki standing rule, stating that in a false advertising ease under 15 U.S.C. § 1125(a)(1)(B), the plaintiff must allege “a discernibly competitive injury” in order to have standing. Id. at 1109; see also Barrus v. Sylvania, 55 F.3d 468, 470 (9th Cir.1995) (under § 1125(a)(1)(B), false advertising must be “harmful to the plaintiffs ability to compete with the defendant.”). By contrast, the Waits court held that in a trademark infringement or “false association” case under 15 U.S.C. § 1125(a)(1)(A), there was no need to allege competitive injury. Waits, 978 F.2d at 1110. In such a case, the trademark holder is attempting to “con-trole ] the commercial exploitation of his or her identity[,]” and not necessarily prevent unfair competition. Plaintiffs allegations against Ellis fall entirely within the first category — traditional false advertising or unfair competition under 15 U.S.C. § 1125(a)(1)(B). All of Plaintiffs claims against Ellis center on his alleged misrepresentations concerning the “nature, characteristics, [or] qualities” of the laser systems he possesses. § 1125(a)(1)(B). None of Plaintiffs allegations against Ellis concern “the affiliation, connection, or association of [Defendant] with another person, or as to the origin, sponsorship, or approval of [Defendant’s] goods, services, or commercial activities[.]” § 1125(a)(1)(A). Accordingly, in order to have standing to sue Ellis, Plaintiff must allege “a discernibly competitive injury” caused by Ellis’ conduct. Plaintiff asserts that it has made this allegation. In ¶ 23 of the FASC, Plaintiff alleges that “Summit’s goal is to be a major participant in all aspects of the developing multi-billion dollar market for laser alternatives to glasses, contact lenses and manual ophthalmic surgery.” FASC ¶ 23 (emphasis added). As part of its attempt to become a “major participant in all aspects of the developing multi-billion dollar market,” Summit claims that it has opened “Summit Vision Centers,” where it provides laser surgery to patients. Plaintiffs Opposition at 40. Summit also asserts that these Centers are in California, in direct competition with Ellis. Id. However, the FASC does not mention the “Summit Vision Centers” at all. The FASC primarily describes Summit as a seller of “products and services,” such as the Excimer laser. See FASC ¶ 24. Plaintiff also alleges that it “has become a world leader in the development, manufacture, sale and servicing of trademarked state-of-the-art laser systems. These systems are designed to permit ophthalmologists to correct common human vision disorders!!]” FASC ¶ 17. Further, Summit alleges that it trains physicians in the use of the Summit systems. FASC ¶ 29. Nowhere in the FASC does Summit allege that it has actually opened clinics to compete with other ophthalmologists. Nevertheless, giving Plaintiff the benefit of the doubt (as the Court must do on a 12(b)(6) motion), “all aspects” of the laser optics business could reasonably include some form of vision center in closer competition with Ellis. Accordingly, the Court will not dismiss Plaintiffs Lanham Act claim against Ellis at this stage. Having disposed of the standing issue for now, the Court now turns to Ellis’ alleged misrepresentations. (1) Statements Indicating FDA Approval Plaintiff alleges that Ellis has repeatedly indicated that the ExciMed machine he uses has been approved by the FDA. For example, Plaintiff alleges that the statements in the “Patient’s Guide” misleadingly give the false impression that the FDA has approved Ellis’ ExeiMed UV 200LA laser. FASC ¶ 65(e). Indeed, at the beginning of Chapter 12, the “Patient Guide” states that “the Summit Excimed model has been approved for therapeutic use.” Exhibit 26, p. 105. Further, on page 117, as part of the answer sheet to a “True-False” test, the “Patient Guide” states that “only the Summit Ex-cimed laser has been approved for therapeutic use by the FDA[.]” Exhibit 26, p. 115. In addition, the patient consent statement accompanying the “Patient Guide” states that “Exeimer laser keratectomy is presently only approved by the FDA to remove corneal surface scars and irregularities!)]” Exhibit 26, p. 117. On page 128, the Guide states that “[t]he ‘Excimed’ exeimer laser (Summit Technology, Inc.) that Dr. Ellis will be using in the surgical procedure to correct your eyesight has been approved by the FDA only for PTK[.]” Exhibit 26, p. 125. Ellis makes the identical statement in a LASIK patent consent brochure. See Exhibit 27, p. 140 and FASC ¶ 66. Further, Plaintiff alleges that on April 7, 1995, Ellis circulated a letter to numerous doctors in which he stated that “[t]he FDA has recently approved the Excimed, Exeimer Laser” and that he possessed such a laser. See FASC ¶ 67 and Exhibit 28. In addition, Plaintiff alleges that on November 1, 1995, Ellis issued a press release heralding the FDA approval of the ExeiMed for certain uses, and stating that “Ellis has been the first in the Bay Area to use the exeimer laser with hundreds of laser cases[.]” FASC ¶¶ 68-69 and Exhibit 29. Plaintiff alleges a number of other, similar statements. See FASC ¶¶ 71-79. The Court agrees that these statements give the impression that the ExeiMed laser used by Ellis has been approved by the FDA. There is no qualification that the Exeimer laser actually used by Dr. Ellis is not covered by the official FDA approval. Without such a qualification, the statement leaves the false i