The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Lasercomb.
| Device ID | K060305 |
| 510k Number | K060305 |
| Device Name: | HAIRMAX LASERCOMB |
| Classification | Laser, Comb, Hair |
| Applicant | LEXINGTON INTERNATIONAL, LLC 1700 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward Basile |
| Correspondent | Edward Basile LEXINGTON INTERNATIONAL, LLC 1700 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2007-01-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HAIRMAX LASERCOMB 85752703 4391016 Live/Registered |
LEXINGTON INTERNATIONAL, LLC. 2012-10-12 |
![]() HAIRMAX LASERCOMB 78074186 2700352 Dead/Cancelled |
Lexington International, LLC 2001-07-16 |