Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500631.htm
Timestamp: 2019-04-25 07:52:03+00:00

Document:
During an inspection of your firm located in Farmers Branch, Texas, on August 5, 2015, through August 13, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm markets and distributes the Eclipse MicroPen Elite. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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.
Our inspections, and review of materials collected during the inspections, revealed that the Eclipse MicroPen Elite 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 Eclipse MicroPen Elite is also misbranded under section 502(o) 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 section 510(k) of the Act, 21 U.S.C. § 360(k).
Specifically, FDA has reviewed product labeling for the Eclipse MicroPen Elite, including your firm’s website located at www.eclipseaesthetics.com, brochures, and pamphlets, which revealed that the Eclipse MicroPen Elite system allows for controlled collagen induction therapy by creating micro injuries in the skin which trigger new collagen synthesis, and is marketed to treat conditions such as the appearance of moderate to deep wrinkles and stretch marks.
Based on FDA’s review of the documents collected during the above-referenced inspection, including our review of your firm’s website, the Eclipse MicroPen Elite appears to consist of a stamp of needles that is controlled by a motor in order to make multiple controlled-depth penetrations perpendicularly into the skin while the operator moves the Eclipse MicroPen Elite across the skin surface.
We also note that Eclipse MicroPen Elite labeling indicates that it is a Class I FDA registered device for microdermabrasion and the treatment of scars; the device is listed with FDA as Powered Dermabrasion Device classified under 21 CFR 878.4820. In general, devices classified under 21 CFR 878.4820 are exempt from premarket notification. Generic devices of this type have abrasion substrates, which are brushes, rasps, and burrs that are intended to abrade and remove layers of the skin via shear force. Unlike the 510(k) exempt powered dermabrasion brushes, the Eclipse MicroPen Elite is intended to achieve its clinical effect by penetrating the skin.
At this time, the safe ranges for needle lengths, penetration depths, and speeds of the device are unknown. Therefore, FDA has safety concerns regarding the potential for the needles to damage vessels and nerves. The Eclipse MicroPen Elite employs a different fundamental scientific technology than a device classified under 21 CFR 878.4820. Therefore, the Eclipse MicroPen Elite exceeds the limitations of exemptions from section 510(k), described in 21 CFR 878.9(b), and it is not exempt from premarket notification.
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. 21 CFR 807.81(b). 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.
Our office requests that your firm immediately cease activities that result in the misbranding and/or adulteration of the Eclipse MicroPen Elite, such as the commercial distribution of the device for the uses discussed above.
Your firm’s response should be sent to: Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: Jeff R. Wooley, Compliance Officer at 214-253-5251.

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