The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Laser.
| Device ID | K180885 |
| 510k Number | K180885 |
| Device Name: | HairMax Laser |
| Classification | Laser, Comb, Hair |
| Applicant | Lexington International, LLC 1040 Holland Drive Boca Raton, FL 33487 |
| Contact | David Michaels |
| Correspondent | Raymond R Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, NJ 07928 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-04 |
| Decision Date | 2018-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856823006725 | K180885 | 000 |
| 00856823006718 | K180885 | 000 |
| 00856823006701 | K180885 | 000 |
| 00856823006619 | K180885 | 000 |
| 00850016973078 | K180885 | 000 |
| 00856823006046 | K180885 | 000 |