ClearanceBrief
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)
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Top companies in OAP

Company510(k)sRecalls
Capillus80
Lexington International, LLC80
Shenzhen Kaiyan Medical Equipment Co., Ltd.50
Theradome, Inc.50
Wontech50
Apira Science, Inc.40
Freedom Laser Therapy, Inc.40
Hubei Yjt Technology Co.,Ltd30
Light Tree Ventures Europe B.V.30
Nutra Luxe MD, LLC30
Decided510(k)Device and applicantCode
Oct 9, 2026K262834Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5
Shenzhen Jianchao Intelligent Technology Co., Ltd., CN
OAP
Sep 24, 2026K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
Shenzhen Nuon Medical Equipment Co., Ltd., CN
OAP
Sep 23, 2026K262254Hair Growth Comb (X-GC01)
Guangdong Ashmore Health Technology Co., Ltd., CN
OAP
Jul 17, 2026K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
Shenzhen Chuanghong Zhilian Technology Co., Ltd., CN
OAP
Jun 26, 2026K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, H
Ziree Co., Ltd., CN
OAP
Jun 16, 2026K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
Zdeer Technology (Henan) Co., Ltd., CN
OAP
Jun 16, 2026K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
Hubei Yjt Technology Co.,Ltd, CN
OAP
Jun 5, 2026K251684Alma TED+ System
Alma Lasers, Inc.
OAP
Jan 23, 2026K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OAP
Dec 24, 2025K253349Hair Regrowth Cap (Model: T-119-HRC)
Light Tree Ventures Europe B.V., NL
OAP
Oct 30, 2025K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OAP
Oct 22, 2025K252325Hair Growth Laser Cap
Cosmo Far East Technology Limited, CN
OAP
Jun 17, 2025K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OAP
Jun 5, 2025K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)
Shenzhen Idea Light Limited, CN
OAP
Apr 29, 2025K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA4
Dongguan Boyuan Intelligent Technology Co.,Ltd, CN
OAP
Dec 11, 2024K242747FAQ™ (302)
Foreo, Inc.
OAP
Dec 2, 2024K242619GroWell BT Hair Growth System (GW10042)
Apira Science, Inc.
OAP
Nov 20, 2024K242363HIGHERDOSE Red Light Hat (HG-120K)
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OAP
Nov 8, 2024K241342Hair Growth Comb (SZ-23,SZ-23A)
Shenzhen Nuon Medical Equipment Co., Ltd., CN
OAP
Nov 1, 2024K242620Breo Laser Hair Growth Comb (Scalp 3L)
Shenzhen Breo Technology Co., Ltd., CN
OAP
Oct 11, 2024K240472PBM Hair Therapy Cap
Dongguan Tutamen Metalwork Co., Ltd., CN
OAP
Sep 17, 2024K240689Robin's Egg
Telebrands Corporation
OAP
Sep 13, 2024K242441Revian Lyte (10011)
Revian, Inc.
OAP
May 22, 2024K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
OAP
Feb 7, 2024K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Wontech Co., Ltd., KR
OAP
Oct 24, 2023K232356Laser Cap, Model: Hat-01
Hubei Yjt Technology Co.,Ltd, CN
OAP
Jul 31, 2023K231321Nooance Led And Laser Helmet
Shenzhen Kaiyan Medical Equipment Co., Ltd., CN
OAP
Jun 23, 2023K231153Neuhat Hair Growth System; ibeauty.com Laser Cap
Nature, Inc.redible, Inc.
OAP
Jun 14, 2023K222790F65 Laser System
Lumenis Be, Ltd., IL
OAP
May 23, 2023K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
Hubei Yjt Technology Co.,Ltd, CN
OAP
Apr 28, 2023K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
Light Tree Ventures Europe B.V., NL
OAP
Apr 28, 2023K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Wontech Co., Ltd., KR
OAP
Apr 5, 2023K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
Light Tree Ventures Europe B.V., NL
OAP
Nov 18, 2022K222477Hair Growth Device
Dongguan Lescolton Medical Equipment Co., Ltd., CN
OAP
Nov 16, 2022K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extr
Xtrallux, LLC
OAP
Oct 13, 2022K222081ID-510 iRestore Elite
Freedom Laser Therapy, Inc.
OAP
Jun 24, 2022K213789Intelligence LaserComb
Yibin Yingtong Intelligent Technology Co., Ltd., CN
OAP
May 26, 2022K213027Laser Hair Growth Comb
Kam Yuen Plastic Products , Ltd., CN
OAP
May 12, 2022K213025Laser hair growth helmet
Kam Yuen Plastic Products , Ltd., CN
OAP
Apr 20, 2022K220543Auxo A300, A150 and APod
Auxo Hair, LLC
OAP
Jan 19, 2022K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
Shenzhen Cosbeauty Technology Co., Ltd., CN
OAP
Dec 22, 2021K213094ID-500 iRestore Hair Growth System
Freedom Laser Therapy, Inc.
OAP
Jul 20, 2021K211192Grivamax Family of Lasers, Models 272 and 148
Leana Orders, Inc.
OAP
Jun 29, 2021K211038Biophotas Celluma RESTORE
Biophotas, Inc.
OAP
Apr 16, 2021K210169Hair Growth Device
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd., CN
OAP
Mar 29, 2021K203826LaserCap Family of Lasers 300, 224, 120 & 80
Transdermal Cap, Inc.
OAP
Dec 8, 2020K202983easy Hairfull
Y & J Bio Co., Ltd., KR
OAP
Dec 8, 2020K202631iHelmet Laser Comb
Slinph Technologies Co., Ltd., CN
OAP
Dec 3, 2020K193008Tricoglam Home Use
Advihair S.R.L., IT
OAP
Sep 1, 2020K201854CAPOGEN Laser Cap
Nature, Inc.redible, Inc.
OAP

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