Product Code: OAP FDA class 2 21 CFR 890.5500

Laser, Comb, Hair

Physical Medicine

The Laser, Comb, Hair (product code OAP) is a low-level laser therapy device in comb form intended to promote hair growth in males with androgenic alopecia classified as Norwood-Hamilton class IIa to V. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 890.5500 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.

View on FDA

510(k)s

110

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: OAP
Device Class: FDA class 2
Regulation Number: 890.5500
Medical Specialty: Physical Medicine
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 110 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260899	Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)	Jun 16, 2026	Substantially Equivalent	Zdeer Technology (Henan) Co., Ltd.
K253231	Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)	Jun 16, 2026	Substantially Equivalent	Hubei Yjt Technology Co.,Ltd
K251684	Alma TED+ System	Jun 05, 2026	Substantially Equivalent	Alma Lasers, Inc.
K253669	TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)	Jan 23, 2026	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.
K253349	Hair Regrowth Cap (Model: T-119-HRC)	Dec 24, 2025	Substantially Equivalent	Light Tree Ventures Europe B.V.
K252414	Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)	Oct 30, 2025	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.
K252325	Hair Growth Laser Cap	Oct 22, 2025	Substantially Equivalent	Cosmo Far East Technology Limited
K251017	CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)	Jun 17, 2025	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.
K250467	Red Light Hair Growth Cap (LP-RJVGRW-BLK)	Jun 05, 2025	Substantially Equivalent	Shenzhen Idea Light Limited
K250308	Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)	Apr 29, 2025	Substantially Equivalent	Dongguan Boyuan Intelligent Technology Co.,Ltd
K242747	FAQ (302)	Dec 11, 2024	Substantially Equivalent	Foreo, Inc.
K242619	GroWell BT Hair Growth System (GW10042)	Dec 02, 2024	Substantially Equivalent	Apira Science, Inc.
K242363	HIGHERDOSE Red Light Hat (HG-120K)	Nov 20, 2024	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.
K241342	Hair Growth Comb (SZ-23,SZ-23A)	Nov 08, 2024	Substantially Equivalent	Shenzhen Nuon Medical Equipment Co., Ltd.
K242620	Breo Laser Hair Growth Comb (Scalp 3L)	Nov 01, 2024	Substantially Equivalent	Shenzhen Breo Technology Co., Ltd.
K240472	PBM Hair Therapy Cap	Oct 11, 2024	Substantially Equivalent	Dongguan Tutamen Metalwork Co., Ltd.
K240689	Robin's Egg	Sep 17, 2024	Substantially Equivalent	Telebrands Corporation
K242441	Revian Lyte (10011)	Sep 13, 2024	Substantially Equivalent	Revian, Inc.
K240456	Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap	May 22, 2024	Substantially Equivalent	Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
K240064	Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom	Feb 07, 2024	Substantially Equivalent	Wontech Co., Ltd.
K232356	Laser Cap, Model: Hat-01	Oct 24, 2023	Substantially Equivalent	Hubei Yjt Technology Co.,Ltd
K231321	Nooance Led And Laser Helmet	Jul 31, 2023	Substantially Equivalent	Shenzhen Kaiyan Medical Equipment Co., Ltd.
K231153	Neuhat Hair Growth System; ibeauty.com Laser Cap	Jun 23, 2023	Substantially Equivalent	Nature, Inc.redible, Inc.
K222790	F65 Laser System	Jun 14, 2023	Substantially Equivalent	Lumenis Be, Ltd.
K230134	Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002	May 23, 2023	Substantially Equivalent	Hubei Yjt Technology Co.,Ltd
K230597	Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)	Apr 28, 2023	Substantially Equivalent	Light Tree Ventures Europe B.V.
K223862	Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp	Apr 28, 2023	Substantially Equivalent	Wontech Co., Ltd.
K230336	CurrentBody Skin Led Hair Regrowth(Model: MZ-07)	Apr 05, 2023	Substantially Equivalent	Light Tree Ventures Europe B.V.
K222477	Hair Growth Device	Nov 18, 2022	Substantially Equivalent	Dongguan Lescolton Medical Equipment Co., Ltd.
K222364	Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)	Nov 16, 2022	Substantially Equivalent	Xtrallux, LLC
K222081	ID-510 iRestore Elite	Oct 13, 2022	Substantially Equivalent	Freedom Laser Therapy, Inc.
K213789	Intelligence LaserComb	Jun 24, 2022	Substantially Equivalent	Yibin Yingtong Intelligent Technology Co., Ltd.
K213027	Laser Hair Growth Comb	May 26, 2022	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.
K213025	Laser hair growth helmet	May 12, 2022	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.
K220543	Auxo A300, A150 and APod	Apr 20, 2022	Substantially Equivalent	Auxo Hair, LLC
K213447	LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.	Jan 19, 2022	Substantially Equivalent	Shenzhen Cosbeauty Technology Co., Ltd.
K213094	ID-500 iRestore Hair Growth System	Dec 22, 2021	Substantially Equivalent	Freedom Laser Therapy, Inc.
K211192	Grivamax Family of Lasers, Models 272 and 148	Jul 20, 2021	Substantially Equivalent	Leana Orders, Inc.
K211038	Biophotas Celluma RESTORE	Jun 29, 2021	Substantially Equivalent	Biophotas, Inc.
K210169	Hair Growth Device	Apr 16, 2021	Substantially Equivalent	Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.
K203826	LaserCap Family of Lasers 300, 224, 120 & 80	Mar 29, 2021	Substantially Equivalent	Transdermal Cap, Inc.
K202983	easy Hairfull	Dec 08, 2020	Substantially Equivalent	Y & J Bio Co., Ltd.
K202631	iHelmet Laser Comb	Dec 08, 2020	Substantially Equivalent	Slinph Technologies Co., Ltd.
K193008	Tricoglam Home Use	Dec 03, 2020	Substantially Equivalent	Advihair S.R.L.
K201854	CAPOGEN Laser Cap	Sep 01, 2020	Substantially Equivalent	Nature, Inc.redible, Inc.
K200464	LG Pra. L Derma LD Scalp Care	Jul 23, 2020	Substantially Equivalent	Lg Electronics.Inc
K200929	Hair Growth System	Jun 03, 2020	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K192552	Irradiation Cosmetic Device	Apr 17, 2020	Substantially Equivalent	Chongqing Peninsula Medical Technology Co., Ltd.
K193667	Shapiro MD model laser 272	Mar 25, 2020	Substantially Equivalent	Conversion Labs, Pr, LLC
K192585	Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap	Jan 29, 2020	Substantially Equivalent	Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
K190467	iHelmet Hair Growth System	Dec 26, 2019	Substantially Equivalent	Slinph Technologies Co., Ltd.
K192627	Laser Hair Growth Cap	Dec 13, 2019	Substantially Equivalent	Shang FA Biotechnology Co.
K191754	Hair Growth System	Nov 22, 2019	Substantially Equivalent	Kunshan Bella Optical Technology Co., Ltd.
K192425	Hair Boom 69, Hair Boom Air, Ulike Hair UpUp	Sep 30, 2019	Substantially Equivalent	Wontech Co., Ltd.
K192012	Capillus 112, Capillus 244	Sep 12, 2019	Substantially Equivalent	Capillus
K191154	Hair Boom 69	Jul 29, 2019	Substantially Equivalent	Wontech
K190685	Hair Growth System	Jul 26, 2019	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.
K183417	iRestore Professional 282	May 17, 2019	Substantially Equivalent	Freedom Laser Therapy, Inc.
K183329	Laser Hair Therapy	Jan 16, 2019	Substantially Equivalent	Omm Imports, Inc. D/B/A Zero Gravity
K182562	Hair Boom 69	Nov 16, 2018	Substantially Equivalent	Wontech
K182501	Hair Laser Headband	Oct 26, 2018	Substantially Equivalent	Pulsaderm, LLC
K181878	Kiierr 272 Laser, Kiierr 148 Laser	Sep 05, 2018	Substantially Equivalent	Kiierr International, LLC
K181308	SuperGrow 272, Ultimate 272	Aug 15, 2018	Substantially Equivalent	Super Grow Lasers
K181253	Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup	Aug 10, 2018	Substantially Equivalent	Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
K180885	HairMax Laser	Jun 20, 2018	Substantially Equivalent	Lexington International, LLC
K180617	Hair Up	Jun 01, 2018	Substantially Equivalent	Y & J Bio Co., Ltd.
K180460	Theradome LH40	May 18, 2018	Substantially Equivalent	Theradome, Inc.
K173846	DermaScalp Laser Cap	Mar 21, 2018	Substantially Equivalent	Dermascalp, LLC
K173729	REVIAN RED	Feb 28, 2018	Substantially Equivalent	Photonmd, Inc.
K173678	Diode Laser Cap	Feb 28, 2018	Substantially Equivalent	Cosmo Far East Technology Limited
K171835	Irradiation Aesthetic Device	Jan 30, 2018	Substantially Equivalent	Chongqing Peninsula Medical Technology Co., Ltd.
K173843	illumiflow 148 Laser Cap	Jan 26, 2018	Substantially Equivalent	Eglobal, LLC
K171775	Theradome LH80 PRO	Jan 09, 2018	Substantially Equivalent	Theradome, Inc.
K172968	Hair Up	Jan 05, 2018	Substantially Equivalent	Y & J Bio Co., Ltd.
K172982	SuperGrow 272, Ultimate 272	Dec 19, 2017	Substantially Equivalent	Super Grow Lasers
K171895	Grivamax Hair Growth System	Aug 22, 2017	Substantially Equivalent	Leana Orders, Inc.
K162782	iHelmet Hair Growth System	Apr 04, 2017	Substantially Equivalent	Slinph Technologies Co., Ltd.
K162071	IllumiFlow Laser Cap	Feb 24, 2017	Substantially Equivalent	Eglobal, LLC
K163170	Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352	Jan 31, 2017	Substantially Equivalent	Capillus, LLC
K162994	Capillus302, Capillus312, Capillus352	Nov 18, 2016	Substantially Equivalent	Capillus, LLC
K161875	LaserCap300, LaserCap224, LaserCap120, LaserCap80	Sep 30, 2016	Substantially Equivalent	Transdermal Cap, Inc.
K160728	NutraStim Hair Laser Helmet	Sep 16, 2016	Substantially Equivalent	Nutra Luxe MD, LLC
K161046	Laser Helmet LH40-EVO	May 12, 2016	Substantially Equivalent	Theradome, Inc.
K160285	Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202	Apr 25, 2016	Substantially Equivalent	Capillus, LLC
K152587	DermaScalp Laser Cap	Feb 04, 2016	Substantially Equivalent	Dermascalp, LLC
K153618	Capillus202	Jan 19, 2016	Substantially Equivalent	Capillus, LLC
K151662	iRestore	Jan 06, 2016	Substantially Equivalent	Freedom Laser Therapy, Inc.
K152019	HairMD	Nov 16, 2015	Substantially Equivalent	Trophy Skin, Inc.
K151516	Capillus82	Aug 21, 2015	Substantially Equivalent	Capillus, LLC
K150613	LaserCap LC Pro and LC Elite	Jul 22, 2015	Substantially Equivalent	Transdermal Cap, Inc.
K150578	Capillus 272 Office Pro	Jun 09, 2015	Substantially Equivalent	Capillus, LLC
K142824	LX-100 Hair Growth Stimulation System	Apr 14, 2015	Substantially Equivalent	Hairlabs International, Inc.
K143199	Capillus 272 Pro	Jan 29, 2015	Substantially Equivalent	Capillus, LLC
K141596	NUTRA STIM HAIR LASER COMB	Jan 08, 2015	Substantially Equivalent	Nutra Luxe MD, LLC
K141588	NUTRA STIM HAIR LASER COMB	Jan 08, 2015	Substantially Equivalent	Nutra Luxe MD, LLC
K140931	IGROW II HAIR GROWTH SYSTEM	Dec 05, 2014	Substantially Equivalent	Apira Science, Inc.
K142573	HairMax LaserComb, HairMax LaserComb	Dec 01, 2014	Substantially Equivalent	Lexington International, LLC
K141567	IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM	Aug 21, 2014	Substantially Equivalent	Apira Science, Inc.
K132646	SUNETICS CLINICAL BIO-STIMULATION LASER	Dec 20, 2013	Substantially Equivalent	Sunetics International Marketing Group, LLC
K121920	LASERBRUSH	Jun 27, 2013	Substantially Equivalent	Sunetics International Marketing Group, LLC
K122950	LASER HELMET	Jun 14, 2013	Substantially Equivalent	Theradome, Inc.
K122248	IGROW II HAIR GROWTH SYSTEM	Dec 05, 2012	Substantially Equivalent	Apira Science, Inc.
K113097	LASER HELMET	Mar 02, 2012	Substantially Equivalent	Theradome, Inc.
K112524	HAIRMAX LASERCOMB	Sep 26, 2011	Substantially Equivalent	Lexington International, LLC
K111714	HAIRMAX DUAL 12	Aug 16, 2011	Substantially Equivalent	Lexington International, LLC
K110233	HAIRMAX LASERCOMB	May 27, 2011	Substantially Equivalent	Lexington International, LLC
K103368	HAIRMAX LASERCOMB	Apr 06, 2011	Substantially Equivalent	Lexington International, LLC
K091496	MEP-90 HAIR GROWTH STIMULATION SYSTEM	Feb 23, 2010	Substantially Equivalent	Midwest Rf, LLC
K093499	HAIRMAX LASERCOMB	Nov 23, 2009	Substantially Equivalent	Lexington International, LLC
K060305	HAIRMAX LASERCOMB	Jan 18, 2007	Substantially Equivalent	Lexington International, LLC