The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Lasercomb.
| Device ID | K103368 | 
| 510k Number | K103368 | 
| Device Name: | HAIRMAX LASERCOMB | 
| Classification | Laser, Comb, Hair | 
| Applicant | LEXINGTON INTERNATIONAL, LLC 1400 SIXTEENTH STREET, NW SUITE 400 Washington, DC 20036 | 
| Contact | Casper E Uldriks Esq. | 
| Correspondent | Casper E Uldriks Esq. LEXINGTON INTERNATIONAL, LLC 1400 SIXTEENTH STREET, NW SUITE 400 Washington, DC 20036 | 
| Product Code | OAP | 
| CFR Regulation Number | 890.5500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2010-11-17 | 
| Decision Date | 2011-04-06 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00856823006145 | K103368 | 000 | 
| 00856823006138 | K103368 | 000 | 
| 00856823006732 | K103368 | 000 | 
| 00856823006534 | K103368 | 000 | 
| 00856823006251 | K103368 | 000 | 
| 00856823006305 | K103368 | 000 | 
| 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 |