FDA Product Code
FDA Product Code OAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5500
510(k) Clearances — 114 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014-12-01 | Traditional | PDF ↗ |
| K141567 | IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM | Apira Science, Inc. | 2014-08-21 | Traditional | PDF ↗ |
| K132646 | SUNETICS CLINICAL BIO-STIMULATION LASER | Sunetics International Marketing Group, LLC | 2013-12-20 | Traditional | PDF ↗ |
| K121920 | LASERBRUSH | Sunetics International Marketing Group, LLC | 2013-06-27 | Traditional | PDF ↗ |
| K122950 | LASER HELMET | Theradome, Inc. | 2013-06-14 | Traditional | PDF ↗ |
| K122248 | IGROW II HAIR GROWTH SYSTEM | Apira Science, Inc. | 2012-12-05 | Traditional | PDF ↗ |
| K113097 | LASER HELMET | Theradome, Inc. | 2012-03-02 | Traditional | PDF ↗ |
| K112524 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-09-26 | Special | PDF ↗ |
| K111714 | HAIRMAX DUAL 12 | Lexington International, LLC | 2011-08-16 | Traditional | PDF ↗ |
| K110233 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-05-27 | Traditional | PDF ↗ |
| K103368 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-04-06 | Traditional | PDF ↗ |
| K091496 | MEP-90 HAIR GROWTH STIMULATION SYSTEM | Midwest Rf, LLC | 2010-02-23 | Traditional | PDF ↗ |
| K093499 | HAIRMAX LASERCOMB | Lexington International, LLC | 2009-11-23 | Special | PDF ↗ |
| K060305 | HAIRMAX LASERCOMB | Lexington International, LLC | 2007-01-18 | Traditional | PDF ↗ |
Product code OAP · Class II · Physical Medicine. Data: openFDA.