Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm342779.htm
Timestamp: 2019-04-22 12:32:55+00:00

Document:
The Food and Drug Administration (FDA) has learned that your firm is marketing Dermarollers, manufactured by Dermaroller GmbH, Wolfenbuettel, Germany, in the United States (U.S.) 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 function of the body.
Medical Dermaroller® therapy triggers angiogenesis and collagenesis by communicating directly with your skin stem cells.
In just a few hours your body begins to naturally regenerate and repair the skin.
This process occurs under the skin surface, deep in the dermis, where all skin cell repair must occur for lasting results.
The treatment of acne scars, burn scars, and stretch marks may require more extensive Medical Dermaroller® therapy.
Only Dermaroller® needles contain carefully blended metal alloys to elicit a specific healing response from the body.
The Home Dermaroller C8 painlessly stimulates your epidermis (uppermost skin layer) to generate thicker, fresher, healthier skin.
Increase micro-circulation below the skin.
Reduce oil levels in the skin.
Mildly reduce wrinkles and fine lines.
Enhance delivery and effectiveness of medical grade skincare creams by 200x.
Promote continuous skin cell production and collagen induction after a medical Dermaroller® procedure.
By using the Home Dermaroller C8® regularly (about 2 to 3 times a week), transitional acne will disappear.
Provides an effective and economical way to treat isolated, well-circumscribed and/or difficult to access scar(s).
Patients experience on average a 75% improvement after treatment of an atrophic scar.
Six fine-precision, medical-grade, stainless steel micro-needles are the optimal number for minimal invasive penetration forces and minimal tissue trauma.
eDermaStamp® procedures take advantage of the body’s own regenerative process by stimulating cell proliferation that results in new collagen formation.
Improve the overall skin texture and facial expression by reducing wrinkles and fine lines.
A review of our records reveals that your firm has registered and listed the Beauty Mouse; Dermaroller; DermaStamp; eDermaStamp; and eDermaStamp needle tips as manual surgical instruments for general use under 21 CFR 878.4800. However, these dermarollers have a different intended use compared to legally-marketed devices classified under 21 CFR 878.4800, manual surgical instrument. The legally-marketed devices consist of either manual or motorized dermabraders indicated for general dermabrasion, scar revision, acne scar revision, and tattoo removal. With the exception of scar treatment, all other intended uses listed above are not within the scope of indications for use for dermabrasion devices. Because your firm’s dermarollers have different intended uses, they exceed the limitations described in 21 CFR 878.9(a) and are not exempt from premarket notification.
“The eDermaStamp® does not take the place of the Medical Dermarollers or DermaStamp®. The eDermStamp® should be used as an adjunct to these devices. . . Electrical-driven needles, especially with high penetration speed (> 50 or more punctures/sec.) and relatively low electro-mechanical power will never penetrate deeper than 0.5 to 1.0 mm on average, regardless of the pressure you apply to the instrument (driver), and regardless of what others claim with their own instruments”.
Compared to generic devices of this type that abrade the skin, incorporation and use of needles to abrade the dermis in this manner employs a different fundamental scientific technology and exceeds the limitations described in 21 CFR 878.9(b). Therefore, your dermarollers are not exempt from premarket notification.
Thus, your firm’s dermarollers 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 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The dermarollers are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(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 its 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.
The Office of Compliance requests that Cynergyimmediately cease the distribution and sale of, and the dissemination of promotional materials for, your firm’s dermaroller devices that are the same as or similar to those described above. Your firm should take prompt action to correct the violations described 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 civil money penalties.
Given the serious nature of the violations of the Act, Dermaroller devicesmanufactured by Dermaroller GmbH 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. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.
Please submit a written response to this letter within fifteen working days from the date you receive this letter, describing your intent to comply with this request. Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #348518 when replying. If you have any questions about the contents of this letter, please contact: Ms. LaShanda Long, Branch Chief, General Surgery Devices Branch, at 301-796-5770, or facsimile at 301-847-8137. 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 firm’s responsibility to ensure that it complies with each applicable requirement of the Act and FDA implementing regulations.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 381