Atlas FDA

OAP

112 FDA 510(k) clearances · Product code

90 daysmedian time to decision
234 days90th percentile
112clearances measured

FDA profile

Official device name
Laser, Comb, Hair
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5500
Medical specialty
Physical Medicine
FDA definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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RecordFirmDate
CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (K261675)Shenzhen Chuanghong Zhilian Technology Co., Ltd.2026-07-17
Laser 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, HR-I4, HR-I5) (K261253)Ziree Co., Ltd.2026-06-26
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (K260899)Zdeer Technology (Henan) Co., Ltd.2026-06-16
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) (K253231)Hubei Yjt Technology Co.,Ltd2026-06-16
Alma TED+ System (K251684)Alma Lasers, Inc.2026-06-05
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (K253669)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-01-23
Hair Regrowth Cap (Model: T-119-HRC) (K253349)Light Tree Ventures Europe B.V.2025-12-24
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (K252414)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-10-30
Hair Growth Laser Cap (K252325)Cosmo Far East Technology Limited2025-10-22
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (K251017)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-06-17
Red Light Hair Growth Cap (LP-RJVGRW-BLK) (K250467)Shenzhen Idea Light Limited2025-06-05
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) (K250308)Dongguan Boyuan Intelligent Technology Co.,Ltd2025-04-29
FAQ™ (302) (K242747)Foreo, Inc.2024-12-11
GroWell BT Hair Growth System (GW10042) (K242619)Apira Science, Inc.2024-12-02
HIGHERDOSE Red Light Hat (HG-120K) (K242363)Shenzhen Kaiyan Medical Equipment Co., Ltd.2024-11-20
Hair Growth Comb (SZ-23,SZ-23A) (K241342)Shenzhen Nuon Medical Equipment Co., Ltd.2024-11-08
Breo Laser Hair Growth Comb (Scalp 3L) (K242620)Shenzhen Breo Technology Co., Ltd.2024-11-01
PBM Hair Therapy Cap (K240472)Dongguan Tutamen Metalwork Co., Ltd.2024-10-11
Robin's Egg (K240689)Telebrands Corporation2024-09-17
Revian Lyte (10011) (K242441)Revian, Inc.2024-09-13
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap (K240456)Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC2024-05-22
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom (K240064)Wontech Co., Ltd.2024-02-07
Laser Cap, Model: Hat-01 (K232356)Hubei Yjt Technology Co.,Ltd2023-10-24
Nooance Led And Laser Helmet (K231321)Shenzhen Kaiyan Medical Equipment Co., Ltd.2023-07-31
Neuhat Hair Growth System; ibeauty.com Laser Cap (K231153)Nature, Inc.redible, Inc.2023-06-23
F65 Laser System (K222790)Lumenis Be, Ltd.2023-06-14
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 (K230134)Hubei Yjt Technology Co.,Ltd2023-05-23
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp (K223862)Wontech Co., Ltd.2023-04-28
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (K230597)Light Tree Ventures Europe B.V.2023-04-28
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) (K230336)Light Tree Ventures Europe B.V.2023-04-05
Hair Growth Device (K222477)Dongguan Lescolton Medical Equipment Co., Ltd.2022-11-18
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) (K222364)Xtrallux, LLC2022-11-16
ID-510 iRestore Elite (K222081)Freedom Laser Therapy, Inc.2022-10-13
Intelligence LaserComb (K213789)Yibin Yingtong Intelligent Technology Co., Ltd.2022-06-24
Laser Hair Growth Comb (K213027)Kam Yuen Plastic Products , Ltd.2022-05-26
Laser hair growth helmet (K213025)Kam Yuen Plastic Products , Ltd.2022-05-12
Auxo A300, A150 and APod (K220543)Auxo Hair, LLC2022-04-20
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. (K213447)Shenzhen Cosbeauty Technology Co., Ltd.2022-01-19
ID-500 iRestore Hair Growth System (K213094)Freedom Laser Therapy, Inc.2021-12-22
Grivamax Family of Lasers, Models 272 and 148 (K211192)Leana Orders, Inc.2021-07-20
Biophotas Celluma RESTORE (K211038)Biophotas, Inc.2021-06-29
Hair Growth Device (K210169)Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.2021-04-16
LaserCap Family of Lasers 300, 224, 120 & 80 (K203826)Transdermal Cap, Inc.2021-03-29
easy Hairfull (K202983)Y & J Bio Co., Ltd.2020-12-08
iHelmet Laser Comb (K202631)Slinph Technologies Co., Ltd.2020-12-08
Tricoglam Home Use (K193008)Advihair S.R.L.2020-12-03
CAPOGEN Laser Cap (K201854)Nature, Inc.redible, Inc.2020-09-01
LG Pra. L Derma LD Scalp Care (K200464)Lg Electronics.Inc2020-07-23
Hair Growth System (K200929)Xuzhou Kernel Medical Equipment Co., Ltd.2020-06-03
Irradiation Cosmetic Device (K192552)Chongqing Peninsula Medical Technology Co., Ltd.2020-04-17
Shapiro MD model laser 272 (K193667)Conversion Labs, Pr, LLC2020-03-25
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap (K192585)Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC2020-01-29
iHelmet Hair Growth System (K190467)Slinph Technologies Co., Ltd.2019-12-26
Laser Hair Growth Cap (K192627)Shang FA Biotechnology Co.2019-12-13
Hair Growth System (K191754)Kunshan Bella Optical Technology Co., Ltd.2019-11-22
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp (K192425)Wontech Co., Ltd.2019-09-30
Capillus 112, Capillus 244 (K192012)Capillus2019-09-12
Hair Boom 69 (K191154)Wontech2019-07-29
Hair Growth System (K190685)Xuzhou Kernel Medical Equipment Co., Ltd.2019-07-26
iRestore Professional 282 (K183417)Freedom Laser Therapy, Inc.2019-05-17
Laser Hair Therapy (K183329)Omm Imports, Inc. D/B/A Zero Gravity2019-01-16
Hair Boom 69 (K182562)Wontech2018-11-16
Hair Laser Headband (K182501)Pulsaderm, LLC2018-10-26
Kiierr 272 Laser, Kiierr 148 Laser (K181878)Kiierr International, LLC2018-09-05
SuperGrow 272, Ultimate 272 (K181308)Super Grow Lasers2018-08-15
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup (K181253)Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC2018-08-10
HairMax Laser (K180885)Lexington International, LLC2018-06-20
Hair Up (K180617)Y & J Bio Co., Ltd.2018-06-01
Theradome LH40 (K180460)Theradome, Inc.2018-05-18
DermaScalp Laser Cap (K173846)Dermascalp, LLC2018-03-21
Diode Laser Cap (K173678)Cosmo Far East Technology Limited2018-02-28
REVIAN RED (K173729)Photonmd, Inc.2018-02-28
Irradiation Aesthetic Device (K171835)Chongqing Peninsula Medical Technology Co., Ltd.2018-01-30
illumiflow 148 Laser Cap (K173843)Eglobal, LLC2018-01-26
Theradome LH80 PRO (K171775)Theradome, Inc.2018-01-09
Hair Up (K172968)Y & J Bio Co., Ltd.2018-01-05
SuperGrow 272, Ultimate 272 (K172982)Super Grow Lasers2017-12-19
Grivamax Hair Growth System (K171895)Leana Orders, Inc.2017-08-22
iHelmet Hair Growth System (K162782)Slinph Technologies Co., Ltd.2017-04-04
IllumiFlow Laser Cap (K162071)Eglobal, LLC2017-02-24
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (K163170)Capillus, LLC2017-01-31
Capillus302, Capillus312, Capillus352 (K162994)Capillus, LLC2016-11-18
LaserCap300, LaserCap224, LaserCap120, LaserCap80 (K161875)Transdermal Cap, Inc.2016-09-30
NutraStim Hair Laser Helmet (K160728)Nutra Luxe MD, LLC2016-09-16
Laser Helmet LH40-EVO (K161046)Theradome, Inc.2016-05-12
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (K160285)Capillus, LLC2016-04-25
DermaScalp Laser Cap (K152587)Dermascalp, LLC2016-02-04
Capillus202 (K153618)Capillus, LLC2016-01-19
iRestore (K151662)Freedom Laser Therapy, Inc.2016-01-06
HairMD (K152019)Trophy Skin, Inc.2015-11-16
Capillus82 (K151516)Capillus, LLC2015-08-21
LaserCap LC Pro and LC Elite (K150613)Transdermal Cap, Inc.2015-07-22
Capillus 272 Office Pro (K150578)Capillus, LLC2015-06-09
LX-100 Hair Growth Stimulation System (K142824)Hairlabs International, Inc.2015-04-14
Capillus 272 Pro (K143199)Capillus, LLC2015-01-29
NUTRA STIM HAIR LASER COMB (K141588)Nutra Luxe MD, LLC2015-01-08
NUTRA STIM HAIR LASER COMB (K141596)Nutra Luxe MD, LLC2015-01-08
IGROW II HAIR GROWTH SYSTEM (K140931)Apira Science, Inc.2014-12-05
HairMax LaserComb, HairMax LaserComb (K142573)Lexington International, LLC2014-12-01
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM (K141567)Apira Science, Inc.2014-08-21
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