Laser, Comb, Hair
FDA product code OAP · Class II (moderate risk) · 21 CFR 890.5500 · Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
112510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Lexington International, LLC 8
- Capillus, LLC 8
- Theradome, Inc. 5
- Wontech Co., Ltd. 5
- Shenzhen Kaiyan Medical Equipment Co., Ltd. 5
- Apira Science, Inc. 4
- Freedom Laser Therapy, Inc. 4
- Light Tree Ventures Europe B.V. 3
- Y & J Bio Co., Ltd. 3
- Slinph Technologies Co., Ltd. 3
- Transdermal Cap, Inc. 3
- Hubei Yjt Technology Co.,Ltd 3
- Nutra Luxe MD, LLC 3
- Xuzhou Kernel Medical Equipment Co., Ltd. 2
- Dermascalp, LLC 2
- Eglobal, LLC 2
- Leana Orders, Inc. 2
- Super Grow Lasers 2
- Chongqing Peninsula Medical Technology Co., Ltd. 2
- Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120…OAP · Traditional | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 07/17/2026SE |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional | Ziree Co., Ltd. | 06/26/2026SE |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…OAP · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/16/2026SE |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 06/16/2026SE |
| K251684 | Alma TED+ SystemOAP · Traditional | Alma Lasers, Inc. | 06/05/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 01/23/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | Light Tree Ventures Europe B.V. | 12/24/2025SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 06/17/2025SE |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK)OAP · Traditional | Shenzhen Idea Light Limited | 06/05/2025SE |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…OAP · Traditional | Dongguan Boyuan Intelligent Technology Co.,Ltd | 04/29/2025SE |
| K242747 | Faq (302)OAP · Traditional | Foreo, Inc. | 12/11/2024SE |
| K242619 | GroWell BT Hair Growth System (GW10042)OAP · Traditional | Apira Science, Inc. | 12/02/2024SE |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 11/20/2024SE |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A)OAP · Traditional | Shenzhen Nuon Medical Equipment Co., Ltd. | 11/08/2024SE |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L)OAP · Traditional | Shenzhen Breo Technology Co., Ltd. | 11/01/2024SE |
| K240472 | PBM Hair Therapy CapOAP · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 10/11/2024SE |
| K240689 | Robin's EggOAP · Traditional | Telebrands Corporation | 09/17/2024SE |
| K242441 | Revian Lyte (10011)OAP · Special | Revian, Inc. | 09/13/2024SE |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapOAP · Special | Plm Worldwide, LLC D/B/A Phoenix Medical… | 05/22/2024SE |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomOAP · Special | Wontech Co., Ltd. | 02/07/2024SE |
| K232356 | Laser Cap, Model: Hat-01OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 10/24/2023SE |
| K231321 | Nooance Led And Laser HelmetOAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/31/2023SE |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser CapOAP · Traditional | Nature, Inc.redible, Inc. | 06/23/2023SE |
| K222790 | F65 Laser SystemOAP · Traditional | Lumenis Be, Ltd. | 06/14/2023SE |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 05/23/2023SE |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)OAP · Traditional | Light Tree Ventures Europe B.V. | 04/28/2023SE |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpOAP · Special | Wontech Co., Ltd. | 04/28/2023SE |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07)OAP · Traditional | Light Tree Ventures Europe B.V. | 04/05/2023SE |
| K222477 | Hair Growth DeviceOAP · Traditional | Dongguan Lescolton Medical Equipment Co., Ltd. | 11/18/2022SE |
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo…OAP · Traditional | Xtrallux, LLC | 11/16/2022SE |
| K222081 | ID-510 iRestore EliteOAP · Traditional | Freedom Laser Therapy, Inc. | 10/13/2022SE |
| K213789 | Intelligence LaserCombOAP · Traditional | Yibin Yingtong Intelligent Technology Co., Ltd. | 06/24/2022SE |
| K213027 | Laser Hair Growth CombOAP · Traditional | Kam Yuen Plastic Products , Ltd. | 05/26/2022SE |
| K213025 | Laser hair growth helmetOAP · Traditional | Kam Yuen Plastic Products , Ltd. | 05/12/2022SE |
| K220543 | Auxo A300, A150 and APodOAP · Traditional | Auxo Hair, LLC | 04/20/2022SE |
| K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.OAP · Traditional | Shenzhen Cosbeauty Technology Co., Ltd. | 01/19/2022SE |
| K213094 | ID-500 iRestore Hair Growth SystemOAP · Traditional | Freedom Laser Therapy, Inc. | 12/22/2021SE |
| K211192 | Grivamax Family of Lasers, Models 272 and 148OAP · Traditional | Leana Orders, Inc. | 07/20/2021SE |
| K211038 | Biophotas Celluma RESTOREOAP · Traditional | Biophotas, Inc. | 06/29/2021SE |
| K210169 | Hair Growth DeviceOAP · Traditional | Dongguan Lescolton Intelligent Electrical… | 04/16/2021SE |
| K203826 | LaserCap Family of Lasers 300, 224, 120 & 80OAP · Traditional | Transdermal Cap, Inc. | 03/29/2021SE |
| K202983 | easy HairfullOAP · Traditional | Y & J Bio Co., Ltd. | 12/08/2020SE |
| K202631 | iHelmet Laser CombOAP · Traditional | Slinph Technologies Co., Ltd. | 12/08/2020SE |
| K193008 | Tricoglam Home UseOAP · Traditional | Advihair S.R.L. | 12/03/2020SE |
| K201854 | CAPOGEN Laser CapOAP · Traditional | Nature, Inc.redible, Inc. | 09/01/2020SE |
| K200464 | LG Pra. L Derma LD Scalp CareOAP · Traditional | Lg Electronics.Inc | 07/23/2020SE |
| K200929 | Hair Growth SystemOAP · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 06/03/2020SE |
| K192552 | Irradiation Cosmetic DeviceOAP · Traditional | Chongqing Peninsula Medical Technology Co., Ltd. | 04/17/2020SE |
| K193667 | Shapiro MD model laser 272OAP · Traditional | Conversion Labs, Pr, LLC | 03/25/2020SE |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapOAP · Special | Pjm Worldwide, LLC D/B/A Phoenix Medical… | 01/29/2020SE |
| K190467 | iHelmet Hair Growth SystemOAP · Traditional | Slinph Technologies Co., Ltd. | 12/26/2019SE |
| K192627 | Laser Hair Growth CapOAP · Traditional | Shang FA Biotechnology Co. | 12/13/2019SE |
| K191754 | Hair Growth SystemOAP · Traditional | Kunshan Bella Optical Technology Co., Ltd. | 11/22/2019SE |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUpOAP · Special | Wontech Co., Ltd. | 09/30/2019SE |
| K192012 | Capillus 112, Capillus 244OAP · Special | Capillus | 09/12/2019SE |
| K191154 | Hair Boom 69OAP · Traditional | Wontech | 07/29/2019SE |
| K190685 | Hair Growth SystemOAP · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 07/26/2019SE |
| K183417 | iRestore Professional 282OAP · Traditional | Freedom Laser Therapy, Inc. | 05/17/2019SE |
| K183329 | Laser Hair TherapyOAP · Traditional | Omm Imports, Inc. D/B/A Zero Gravity | 01/16/2019SE |
| K182562 | Hair Boom 69OAP · Traditional | Wontech | 11/16/2018SE |
| K182501 | Hair Laser HeadbandOAP · Special | Pulsaderm, LLC | 10/26/2018SE |
| K181878 | Kiierr 272 Laser, Kiierr 148 LaserOAP · Traditional | Kiierr International, LLC | 09/05/2018SE |
| K181308 | SuperGrow 272, Ultimate 272OAP · Traditional | Super Grow Lasers | 08/15/2018SE |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupOAP · Traditional | Pjm Worldwide, LLC D/B/A Phoenix Medical… | 08/10/2018SE |
| K180885 | HairMax LaserOAP · Traditional | Lexington International, LLC | 06/20/2018SE |
| K180617 | Hair UpOAP · Traditional | Y & J Bio Co., Ltd. | 06/01/2018SE |
| K180460 | Theradome LH40OAP · Traditional | Theradome, Inc. | 05/18/2018SE |
| K173846 | DermaScalp Laser CapOAP · Traditional | Dermascalp, LLC | 03/21/2018SE |
| K173729 | Revian RedOAP · Traditional | Photonmd, Inc. | 02/28/2018SE |
| K173678 | Diode Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 02/28/2018SE |
| K171835 | Irradiation Aesthetic DeviceOAP · Traditional | Chongqing Peninsula Medical Technology Co., Ltd. | 01/30/2018SE |
| K173843 | illumiflow 148 Laser CapOAP · Special | Eglobal, LLC | 01/26/2018SE |
| K171775 | Theradome LH80 PROOAP · Traditional | Theradome, Inc. | 01/09/2018SE |
| K172968 | Hair UpOAP · Traditional | Y & J Bio Co., Ltd. | 01/05/2018SE |
| K172982 | SuperGrow 272, Ultimate 272OAP · Traditional | Super Grow Lasers | 12/19/2017SE |
| K171895 | Grivamax Hair Growth SystemOAP · Traditional | Leana Orders, Inc. | 08/22/2017SE |
| K162782 | iHelmet Hair Growth SystemOAP · Traditional | Slinph Technologies Co., Ltd. | 04/04/2017SE |
| K162071 | IllumiFlow Laser CapOAP · Traditional | Eglobal, LLC | 02/24/2017SE |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…OAP · Traditional | Capillus, LLC | 01/31/2017SE |
| K162994 | Capillus302, Capillus312, Capillus352OAP · Special | Capillus, LLC | 11/18/2016SE |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80OAP · Traditional | Transdermal Cap, Inc. | 09/30/2016SE |
| K160728 | NutraStim Hair Laser HelmetOAP · Traditional | Nutra Luxe MD, LLC | 09/16/2016SE |
| K161046 | Laser Helmet LH40-EVOOAP · Special | Theradome, Inc. | 05/12/2016SE |
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202OAP · Traditional | Capillus, LLC | 04/25/2016SE |
| K152587 | DermaScalp Laser CapOAP · Traditional | Dermascalp, LLC | 02/04/2016SE |
| K153618 | Capillus202OAP · Special | Capillus, LLC | 01/19/2016SE |
| K151662 | iRestoreOAP · Traditional | Freedom Laser Therapy, Inc. | 01/06/2016SE |
| K152019 | HairMDOAP · Traditional | Trophy Skin, Inc. | 11/16/2015SE |
| K151516 | Capillus82OAP · Special | Capillus, LLC | 08/21/2015SE |
| K150613 | LaserCap LC Pro and LC EliteOAP · Traditional | Transdermal Cap, Inc. | 07/22/2015SE |
| K150578 | Capillus 272 Office ProOAP · Traditional | Capillus, LLC | 06/09/2015SE |
| K142824 | LX-100 Hair Growth Stimulation SystemOAP · Traditional | Hairlabs International, Inc. | 04/14/2015SE |
| K143199 | Capillus 272 ProOAP · Traditional | Capillus, LLC | 01/29/2015SE |
| K141596 | Nutra Stim Hair Laser CombOAP · Traditional | Nutra Luxe MD, LLC | 01/08/2015SE |
| K141588 | Nutra Stim Hair Laser CombOAP · Traditional | Nutra Luxe MD, LLC | 01/08/2015SE |
| K140931 | Igrow II Hair Growth SystemOAP · Traditional | Apira Science, Inc. | 12/05/2014SE |
| K142573 | HairMax LaserComb, HairMax LaserCombOAP · Traditional | Lexington International, LLC | 12/01/2014SE |
| K141567 | Igrow - II Hair Growth System, Igrow Hair Growth SystemOAP · Traditional | Apira Science, Inc. | 08/21/2014SE |
| K132646 | Sunetics Clinical Bio-Stimulation LaserOAP · Traditional | Sunetics International Marketing Group, LLC | 12/20/2013SE |
| K121920 | LaserbrushOAP · Traditional | Sunetics International Marketing Group, LLC | 06/27/2013SE |
| K122950 | Laser HelmetOAP · Traditional | Theradome, Inc. | 06/14/2013SE |
| K122248 | Igrow II Hair Growth SystemOAP · Traditional | Apira Science, Inc. | 12/05/2012SE |
| K113097 | Laser HelmetOAP · Traditional | Theradome, Inc. | 03/02/2012SE |
| K112524 | Hairmax LasercombOAP · Special | Lexington International, LLC | 09/26/2011SE |
| K111714 | Hairmax Dual 12OAP · Traditional | Lexington International, LLC | 08/16/2011SE |
| K110233 | Hairmax LasercombOAP · Traditional | Lexington International, LLC | 05/27/2011SE |
| K103368 | Hairmax LasercombOAP · Traditional | Lexington International, LLC | 04/06/2011SE |
| K091496 | MEP-90 Hair Growth Stimulation SystemOAP · Traditional | Midwest Rf, LLC | 02/23/2010SE |
| K093499 | Hairmax LasercombOAP · Special | Lexington International, LLC | 11/23/2009SE |
| K060305 | Hairmax LasercombOAP · Traditional | Lexington International, LLC | 01/18/2007SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1222-2023 Class II | Recreo Hair Growth Laser CombThe firm distributed the laser products without affixing the warning, aperture, certification, and… | OMM Imports, Inc. dba Zero Gravity | 09/01/2022Open, Classified |