- Eclipse Aesthetics LLC
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
March 28, 2016
Ref: 2016-DAL-WL – 17
VIA UNITED PARCEL SERVICE
Thomas M. O’Brien, CEO
Eclipse Aesthetics, LLC.
13988 Diplomat Drive, Suite 160
Farmers Branch, Texas 75234
Dear Mr. O’Brien:
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.
For example, FDA’s review of the product’s labeling found the following description of the device:
“Automated Micro-Needling (also known as Collagen Induction Therapy or CIT) is a new innovation in aesthetic medicine for the treatment of the appearance of fine lines, acne scars and the improvement of the skin’s texture, tone and color. During this procedure, the Eclipse MicroPen is used to create controlled micro-injuries to the skin in order to aid in the production of collagen and elastin. The skin’s repair process results in a thicker epidermis with a softer appearance of wrinkles. MicroPen Elite also creates micro-channels which allow topical gels, creams and serums to be absorbed more effectively, enhancing the effects in deeper layers of the skin.”
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 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. Also, federal agencies may be advised of the issuance of Warning 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 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) that 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: 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.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Reynaldo R. Rodriguez, Jr.
Dallas District Director