The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Lasercomb, Hairmax Lasercomb.
| Device ID | K142573 |
| 510k Number | K142573 |
| Device Name: | HairMax LaserComb, HairMax LaserComb |
| Classification | Laser, Comb, Hair |
| Applicant | LEXINGTON INTERNATIONAL, LLC 777 YAMATO RD SUITE 105 Boca Raton, FL 33431 |
| Contact | David Michaels |
| Correspondent | Evan P Phelps OLSSON FRANK WEEDA TERMAN MATZ PC 600 NEW HAMPHIRE AVENUE, NW SUITE 500 Washington Dc, DC 20037 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2014-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856823006510 | K142573 | 000 |
| 00850016973047 | K142573 | 000 |