The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Lasercomb.
Device ID | K112524 |
510k Number | K112524 |
Device Name: | HAIRMAX LASERCOMB |
Classification | Laser, Comb, Hair |
Applicant | LEXINGTON INTERNATIONAL, LLC 777 YAMATO RD., SUITE 105 Boca Raton, FL 33431 |
Contact | David Michaels |
Correspondent | David Michaels LEXINGTON INTERNATIONAL, LLC 777 YAMATO RD., SUITE 105 Boca Raton, FL 33431 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-31 |
Decision Date | 2011-09-26 |
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 |