| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue |
Department of Health and Human Services
June 28 2010
VIA UPS EXPRESS
Dr. Xanya Sofra-Weiss
CEO, Director of R&D
Arasys Perfector, LLC
7773 Waikapu Loop
Honolulu, HI 96825
Dear Dr. Weiss:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Arasys, Perfector, Ion Magnum, and iPico Perfector in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your websites; http://www.arasysperfector.com for the Arasys, Perfector, Ion Magnum, and iPico Perfector; and http://www.arasysperfectorusa.com. for the Arasys and Perfector. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act. Specifically, your websites contain statements which represent or suggest that the Arasys is safe and effective in producing the following, but not limited to, effects: muscle building acceleration, stamina increase, strength and performance boost, power detoxification, abs tightening, buttocks contouring, healthy lymphatic drainage promotion, tightening of loose skin, breast enhancement, body revitalization, and cellulite appearance reduction.Additionally, your websites contain statements which represent or suggest that the Perfector, Ion Magnum, and iPico Perfector are adequate and effective in producing the following, but not limited to, effects: erasure of wrinkles, discolorations, acne, and scars.
The Arasys, Perfector, Ion Magnum, and iPico Perfector are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or approved applications for investigational device exemptions (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Waming Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Jennifer Medicus at the Food and Drug Administration, 10903 New Hampshire Avenue, W066-2626, Silver Spring, MD 20993-0002. If you have any questions about the content of this letter please contact Jennifer Medicus via telephone at (301)796-5615 or via facsimile at (301)847-8128.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/s/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health
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