CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-08-16
May 22, 2008
David Michaels, Managing Director
Lexington International, LLC
777 Yamato Road, Suite 105
Boca Raton, FL 33431
Dear Mr. Michaels:
During an inspection of your firm located in Boca Raton, Florida, from November 7 through 9, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the HairMax LaserComb® Premium and SE models. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the HairMax LaserComb® Premium and SE models are 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 devices are 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 devices 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 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.
The HairMax LaserComb® Premium and SE models differ from the cleared Hair Max LaserComb in dose rate, method of delivery, and/or treatment parameters. Specifically, the device cleared under [redacted] uses a single light emitting diode and divides its light into nine (9) separate beams to deliver treatment to the patient. The Premium and SE devices use [redacted] and [redacted] light emitting diodes, respectively, which deliver their light energy individually to the patient. These changes could significantly affect the safety or effectiveness of these devices and therefore, pursuant to 21, CFR 807.81 (a)(3)(i), new 510(k) submissions are required in order to legally market these devices.
In addition, we viewed your Web site, hairmax.com/LaserResearch.aspx. The Web site promotes your product as a laser device that can be used by women to grow hair. The HairMax LaserComb© cleared under 510(k) [redacted] is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. It has not been cleared for use on women. We acknowledge that you have submitted a 510(k) notification that includes hair growth for women. However, you may not market the device for that use until FDA issues an order clearing the device for marketing.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should also include your proposed corrective action regarding violative devices currently in the marketplace and your websites, which were reviewed by FDA on March 5, 2008.
Please send your response to the U.S. Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, please contact Mr. Thomaston at (407) 475-4728.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
