Inspections, Compliance, Enforcement, and Criminal Investigations
Refine, USA, LLC 4/18/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
April 18, 2011
VIA UNITED PARCEL SERVICE
Refine USA, LLC
340 3rd Avenue South STE C
Jacksonville Beach, Florida 32250
RE: VeinGogh Ohmic Thermolysis System
Dear Mr. Smith
Refer to GEN0900605 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing the VeinGogh Ohmic Thermolysis System 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 Internet website http://www.veingogh.com for VeinGogh Ohmic Thermolysis System. The product is a device within the meaning of Section 201(h) of the Act.
The website or linked pages to the website make statements like:
“Medspa and aesthetic physician offices use the VeinGogh Ohmic Thermolysis System to provide a superior solution for the treatment of fine telangiectasia, spider veins and small angiomas, especially recalcitrant vessels that have shown a resistance to sclerotherapy, laser or IPL treatment. VeinGogh is the fast, easy way to reliably treat these and other cosmetically unacceptable conditions, often with less discomfort compared to older therapies.”
“Does VeinGogh only work on veins? No! VeinGogh can also be used to eliminate cherry angiomas, small hemangiomas, skin tags, spider nevi, and even redness of rosacea”
Refine USA, LLC, of Jacksonville Beach Florida, has listed VeinGogh as a needle-type epilator in FDA’s Registration and Listing Database under 21 CFR 878.5350. Epilators are class I devices intended to remove unwanted hair and are exempt from premarket notification. However, claims like those made above and elsewhere in your website exceed the limitations of exemptions from section 510(k) of the Act, 21 U.S.C. 360(k), for epilators. These claims are a major change or modification to the intended use of this device and require a premarket notification under 21 CFR 807.81(a)(3)(ii).
The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is 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 device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
The Office of Compliance requests that Refine USA, LLC immediately cease the dissemination of promotional materials for VeinGogh Ohmic Thermolysis System the same as or similar to those described above. You should take prompt action to correct these violations. 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.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for VeinGogh Ohmic Thermolysis System the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Jason A. Brookbank, Acting Chief, General Surgery Devices Branch at the Food and Drug Administration, 10903 New Hampshire Ave, WO66-3520, Silver Spring, Maryland 20993-0002. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for VeinGogh Ohmic Thermolysis System comply with each applicable requirement of the Act and FDA implementing regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and