Panels › Physical Medicine › Product code OAP · Class 2
Laser, Comb, Hair
Regulation 890.5500
10510(k)s in 12 months (115 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Capillus | 8 | 0 |
| Lexington International, LLC | 8 | 0 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 5 | 0 |
| Theradome, Inc. | 5 | 0 |
| Wontech | 5 | 0 |
| Apira Science, Inc. | 4 | 0 |
| Freedom Laser Therapy, Inc. | 4 | 0 |
| Hubei Yjt Technology Co.,Ltd | 3 | 0 |
| Light Tree Ventures Europe B.V. | 3 | 0 |
| Nutra Luxe MD, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2014 | K140931 | IGROW II HAIR GROWTH SYSTEM Apira Science, Inc. | OAP |
| Dec 1, 2014 | K142573 | HairMax LaserComb, HairMax LaserComb Lexington International, LLC | OAP |
| Aug 21, 2014 | K141567 | IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM Apira Science, Inc. | OAP |
| Dec 20, 2013 | K132646 | SUNETICS CLINICAL BIO-STIMULATION LASER Sunetics International Marketing Group, LLC | OAP |
| Jun 27, 2013 | K121920 | LASERBRUSH Sunetics International Marketing Group, LLC | OAP |
| Jun 14, 2013 | K122950 | LASER HELMET Theradome, Inc. | OAP |
| Dec 5, 2012 | K122248 | IGROW II HAIR GROWTH SYSTEM Apira Science, Inc. | OAP |
| Mar 2, 2012 | K113097 | LASER HELMET Theradome, Inc. | OAP |
| Sep 26, 2011 | K112524 | HAIRMAX LASERCOMB Lexington International, LLC | OAP |
| Aug 16, 2011 | K111714 | HAIRMAX DUAL 12 Lexington International, LLC | OAP |
| May 27, 2011 | K110233 | HAIRMAX LASERCOMB Lexington International, LLC | OAP |
| Apr 6, 2011 | K103368 | HAIRMAX LASERCOMB Lexington International, LLC | OAP |
| Feb 23, 2010 | K091496 | MEP-90 HAIR GROWTH STIMULATION SYSTEM Midwest Rf, LLC | OAP |
| Nov 23, 2009 | K093499 | HAIRMAX LASERCOMB Lexington International, LLC | OAP |
| Jan 18, 2007 | K060305 | HAIRMAX LASERCOMB Lexington International, LLC | OAP |
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