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 |