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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aesthetics Systems Usa Inc 5/22/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

May 22, 2014
 
 
WARNING LETTER
 
 
Via United Parcel Service
 
Mr. Jean Louis Gonella
President
Aesthetics Systems USA, Inc.
1715 E. Wilshire Avenue
Suite No. 712
Santa Ana, California 92705
 
Re: Vitapeel, Vitaderm, Vitalift, Angie Thermocoagulation System, Vitalymph, and Vital-Ultra Systems
Refer to CMS # 424257
 
Dear Mr. Gonella:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Vitapeel Advanced Microdermabrasion System, the Vitaderm 4000 System, the Vitalift System, the Angie Thermocoagulation System, the Vitalymph Pressotherapy System, and the Vital-Ultra Anti-Cellulite System in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
The FDA has reviewed your firm’s website (www.aestheticssystems.com), which states that Aesthetics Systems USA, Inc., is a “full service aesthetics and electrology distribution company that sells and services all products made by Dectro International.” Subsequent FDA review of Dectro International, Inc.’s, website (www.dectro.com) revealed that Aesthetics Systems USA, Inc., operates as the “exclusive distributor of western United States and authorized service center” for Dectro International, Inc.’s, products. Based on this information, Aesthetics Systems USA, Inc., operates as an initial importer for Dectro International, Inc.’s, medical devices, as defined under 21 CFR 807.3(g).
 
The FDA has reviewed your firm’s website (www.aestheticssystems.com) and determined that the Vitapeel Advanced Microdermabrasion System, the Vitaderm 4000 System, the Vitalift System, the Angie Thermocoagulation System, the Vitalymph Pressotherapy System, and the Vital-Ultra Anti-Cellulite System are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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) for these devices as described and marketed.  These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered into interstate commerce for commercial distribution devices with major changes/modifications to their intended use without submitting new premarket notifications to the agency as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(ii). 
 
Vitapeel Advanced Microdermabrasion System
 
A review of Dectro International’s FDA registration and listing has revealed that the Vitapeel Advanced Microdermabrasion System is listed under 21 CFR 878.4820 (Surgical Instrument Motors and Accessories/Attachments). Devices classified under 21 CFR 878.4820 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 878.9(a). There is evidence that the Vitapeel Microdermabrasion device is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.4820 Generic devices of this type are intended to remove dead skin at the skin surface and are intended for general dermabrasion, scar revision, acne scar revision, and tattoo removal. However, according to your firm’s website, the Vitapeel Microdermabrasion device is intended for the following:
 
  • “Reduces edema and activates blood and lymph circulation”
  • “Stimulates cellular renewal”
  • “hyperkeratinization”
  • “Reduces wrinkles, fine lines”
  • “Fades pigment spots and evens the complexion”
 
Because there is evidence that the Vitapeel Advanced Microdermabrasion System is intended for uses that are different from those of legally-marketed devices classified under 21 CFR 878.4820, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from premarket notification. 
 
Vitaderm 4000 System
 
A review of Dectro International’s FDA registration and listing has revealed that the Vitaderm 4000 System is listed under 21 CFR 890.5660 (Electric Therapeutic Massager). Devices classified under 21 CFR 890.5660 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). There is evidence that the Vitaderm 4000 System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660. Generic devices of this type are intendedfor relief of minor muscle aches and pains or temporarily relieve minor muscular pain and tension caused by fatigue or overexertion. However, according to your firm’s website, the Vitaderm 4000 System is intended for the following:
 
  • “Improves skin quality and complexion”
  • “Improves blood and lymph circulation”
  • “Eliminates toxins”
  • “Relieves redness, irritation and inflammation”
  • “Restores pH level”
  • “Facial Electrolifting”
  • “Body remodeling”
  • “Drainage”
  • “Body firming”
 
Because there is evidence that the Vitaderm 4000 System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification. 
 
Vitalift System
 
A review of Dectro International’s FDA registration and listing has revealed that the Vitalift System is listed under 21 CFR 890.5660 (Electric Therapeutic Massager). Devices classified under 21 CFR 890.5660 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). There is evidence that the Vitalift System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660Generic devices of this type are intendedfor relief of minor muscle aches and pains or temporarily relieve minor muscular pain and tension caused by fatigue or overexertion. However, according to your firm’s website, the Vitalift System is marketed with the following claims:
 
  • “Their microcurrent circuitry, controlled by advanced and unique technology, delivers impressive results from facial electrolifting and body remodeling treatments.”
  • “By emitting a very specific microcurrent to facial and body muscles” the Vitalift System is “able to stimulate muscles effectively, to restore the full vigour of youth to the face and body.”
 
Because there is evidence that the Vitalift System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification. 
 
Angie Thermocoagulation System
 
Your firm’s website describes the Angie Thermocoagulation System as a “newcomer at Apilus” and a system “that combines hair removal and thermocoagulation.” Subsequent review of the FDA database revealed that the Apilus Electropil device was cleared under K943928 with the intended use for the permanent removal of hair via electrolysis and/or thermolysis.
 
However, a review of your firm’s website revealed that the Angie Thermocoagulation System is being marketed with the following claims:
 
  • “Its new system called Angie includes specific programs for circulation imperfections, pigment spots and raised imperfections . . .”; and
  • "Simple to use and highly versatile, this device allows beauty professionals to treat telangiectasia, cherry angiomas, molluscum pendulum, skin tags, milia . . .”
 
The above claims represent new intended uses for the Apilus Electropil device, which exceed the intended uses as cleared in K943928. Therefore, the Angie Thermocoagulation System requires the submission of a 510(k).
 
Vitalymph Pressotherapy System
 
A review of Dectro International’s FDA registration and listing has revealed that the Vitalymph Pressotherapy System is listed under 21 CFR 890.5765 (Pressure Applying Device). Devices classified under 21 CFR 890.5765 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). There is evidence that the Vitalymph Pressotherapy System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5765. Generic devices of this type are intendedfor medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. However, according to your firm’s website, the Vitalymph Pressotherapy System is marketed with intended uses for hemo‑lymphatic drainage.
 
Because there is evidence that the Vitalymph Pressotherapy System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5765, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification. 
 
Vital-Ultra Anti-Cellulite System
 
A review of Dectro International’s FDA registration and listing has revealed that the Vital-Ultra Anti-Cellulite System is listed under 21 CFR 890.5660 (Electric Therapeutic Massager). Devices classified under 21 CFR 890.5660 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). There is evidence that the Vital-Ultra Anti-Cellulite System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660Generic devices of this type are intendedfor relief of minor muscle aches and pains or temporarily relieve minor muscular pain and tension caused by fatigue or overexertion. However, your firm is marketing the Vital-Ultra Anti-Cellulite System with intended uses, including but not limited to, the following:
 
  • “Reduces cellulite and fatty lumps”
  • “Provides blood and lymphatic drainage”
  • “Activates circulation and tissue oxygenation”
  • “Body remodeling”
 
Because there is evidence that the Vital-Ultra Anti-Cellulite System is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification. 
 
For devices 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.  21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Additionally, under 21 CFR 807.20(a), as an initial importer, Aesthetics Systems USA, Inc., is required to register its establishment with the FDA.  A review of the FDA’s database was unable to locate such a registration. Therefore, your firm’s devices as listed above are also misbranded under Section 502(o), 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360.
 
The Office of Compliance requests that Aesthetics Systems USA, Inc., immediately cease activities that result in the misbranding or adulteration of these devices, such as the commercial distribution of these devices for the uses discussed above. Aesthetics Systems USA, Inc., and Dectro International, Inc., 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 FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties. 
 
Given the serious nature of the violations of the Act, devicesmanufactured by Dectro International, Inc., are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these products into the United States, known as "detention without physical examination," until these violations are corrected. 
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CMS # 424257 when replying. We remind you that only written communication is considered as official.  If you have any questions about the contents of this letter, please contact: LaShanda M. Long, Chief, Surveillance and Enforcement Branch 1 at (301) 796-5465 or (301) 847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
      Radiological Health
 
 
 
cc:       Clement Beaumont
            President
            Dectro International, Inc.
            1000 Boul.
            Du Parc Technologique
            Quebec, Quebec, Canada G1P 4S3