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 |
|---|---|---|---|
| Jul 23, 2020 | K200464 | LG Pra. L Derma LD Scalp Care Lg Electronics.Inc, KR | OAP |
| Jun 3, 2020 | K200929 | Hair Growth System Xuzhou Kernel Medical Equipment Co., Ltd., CN | OAP |
| Apr 17, 2020 | K192552 | Irradiation Cosmetic Device Chongqing Peninsula Medical Technology Co., Ltd., CN | OAP |
| Mar 25, 2020 | K193667 | Shapiro MD model laser 272 Conversion Labs, Pr, LLC | OAP |
| Jan 29, 2020 | K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP |
| Dec 26, 2019 | K190467 | iHelmet Hair Growth System Slinph Technologies Co., Ltd., CN | OAP |
| Dec 13, 2019 | K192627 | Laser Hair Growth Cap Shang FA Biotechnology Co., TW | OAP |
| Nov 22, 2019 | K191754 | Hair Growth System Kunshan Bella Optical Technology Co., Ltd., CN | OAP |
| Sep 30, 2019 | K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp Wontech Co., Ltd., KR | OAP |
| Sep 12, 2019 | K192012 | Capillus 112, Capillus 244 Capillus | OAP |
| Jul 29, 2019 | K191154 | Hair Boom 69 Wontech, KR | OAP |
| Jul 26, 2019 | K190685 | Hair Growth System Xuzhou Kernel Medical Equipment Co., Ltd., CN | OAP |
| May 17, 2019 | K183417 | iRestore Professional 282 Freedom Laser Therapy, Inc. | OAP |
| Jan 16, 2019 | K183329 | Laser Hair Therapy Omm Imports, Inc. D/B/A Zero Gravity | OAP |
| Nov 16, 2018 | K182562 | Hair Boom 69 Wontech, KR | OAP |
| Oct 26, 2018 | K182501 | Hair Laser Headband Pulsaderm, LLC | OAP |
| Sep 5, 2018 | K181878 | Kiierr 272 Laser, Kiierr 148 Laser Kiierr International, LLC | OAP |
| Aug 15, 2018 | K181308 | SuperGrow 272, Ultimate 272 Super Grow Lasers | OAP |
| Aug 10, 2018 | K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP |
| Jun 20, 2018 | K180885 | HairMax Laser Lexington International, LLC | OAP |
| Jun 1, 2018 | K180617 | Hair Up Y & J Bio Co., Ltd., KR | OAP |
| May 18, 2018 | K180460 | Theradome LH40 Theradome, Inc. | OAP |
| Mar 21, 2018 | K173846 | DermaScalp Laser Cap Dermascalp, LLC | OAP |
| Feb 28, 2018 | K173729 | REVIAN RED Photonmd, Inc. | OAP |
| Feb 28, 2018 | K173678 | Diode Laser Cap Cosmo Far East Technology Limited, CN | OAP |
| Jan 30, 2018 | K171835 | Irradiation Aesthetic Device Chongqing Peninsula Medical Technology Co., Ltd., CN | OAP |
| Jan 26, 2018 | K173843 | illumiflow 148 Laser Cap Eglobal, LLC | OAP |
| Jan 9, 2018 | K171775 | Theradome LH80 PRO Theradome, Inc. | OAP |
| Jan 5, 2018 | K172968 | Hair Up Y & J Bio Co., Ltd., KR | OAP |
| Dec 19, 2017 | K172982 | SuperGrow 272, Ultimate 272 Super Grow Lasers | OAP |
| Aug 22, 2017 | K171895 | Grivamax Hair Growth System Leana Orders, Inc. | OAP |
| Apr 4, 2017 | K162782 | iHelmet Hair Growth System Slinph Technologies Co., Ltd., CN | OAP |
| Feb 24, 2017 | K162071 | IllumiFlow Laser Cap Eglobal, LLC | OAP |
| Jan 31, 2017 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 Capillus, LLC | OAP |
| Nov 18, 2016 | K162994 | Capillus302, Capillus312, Capillus352 Capillus, LLC | OAP |
| Sep 30, 2016 | K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 Transdermal Cap, Inc. | OAP |
| Sep 16, 2016 | K160728 | NutraStim Hair Laser Helmet Nutra Luxe MD, LLC | OAP |
| May 12, 2016 | K161046 | Laser Helmet LH40-EVO Theradome, Inc. | OAP |
| Apr 25, 2016 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 Capillus, LLC | OAP |
| Feb 4, 2016 | K152587 | DermaScalp Laser Cap Dermascalp, LLC | OAP |
| Jan 19, 2016 | K153618 | Capillus202 Capillus, LLC | OAP |
| Jan 6, 2016 | K151662 | iRestore Freedom Laser Therapy, Inc. | OAP |
| Nov 16, 2015 | K152019 | HairMD Trophy Skin, Inc. | OAP |
| Aug 21, 2015 | K151516 | Capillus82 Capillus, LLC | OAP |
| Jul 22, 2015 | K150613 | LaserCap LC Pro and LC Elite Transdermal Cap, Inc. | OAP |
| Jun 9, 2015 | K150578 | Capillus 272 Office Pro Capillus, LLC | OAP |
| Apr 14, 2015 | K142824 | LX-100 Hair Growth Stimulation System Hairlabs International, Inc. | OAP |
| Jan 29, 2015 | K143199 | Capillus 272 Pro Capillus, LLC | OAP |
| Jan 8, 2015 | K141596 | NUTRA STIM HAIR LASER COMB Nutra Luxe MD, LLC | OAP |
| Jan 8, 2015 | K141588 | NUTRA STIM HAIR LASER COMB Nutra Luxe MD, LLC | OAP |
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