The following data is part of a premarket notification filed by Lexington International, Llc with the FDA for Hairmax Dual 12.
| Device ID | K111714 |
| 510k Number | K111714 |
| Device Name: | HAIRMAX DUAL 12 |
| Classification | Laser, Comb, Hair |
| Applicant | LEXINGTON INTERNATIONAL, LLC 1400 SIXTEENTH STREET, NW SUITE 400 Washington, DC 20036 |
| Contact | Casper E Uldricks Esq. |
| Correspondent | Casper E Uldricks 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 | 2011-06-20 |
| Decision Date | 2011-08-16 |
| Summary: | summary |