FDA Product Code
FDA Product Code OAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5500
510(k) Clearances — 114 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2026-09-24 | Traditional | PDF ↗ |
| K262254 | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | 2026-09-23 | Traditional | PDF ↗ |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026-07-17 | Traditional | PDF ↗ |
| K261253 | 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) | Ziree Co., Ltd. | 2026-06-26 | Traditional | PDF ↗ |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | 2026-06-16 | Traditional | PDF ↗ |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-16 | Traditional | PDF ↗ |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026-06-05 | Traditional | PDF ↗ |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-23 | Traditional | PDF ↗ |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | 2025-12-24 | Traditional | PDF ↗ |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-30 | Traditional | PDF ↗ |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | 2025-10-22 | Traditional | PDF ↗ |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-17 | Traditional | PDF ↗ |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | 2025-06-05 | Traditional | PDF ↗ |
| 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) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-04-29 | Traditional | PDF ↗ |
| K242747 | FAQ (302) | Foreo, Inc. | 2024-12-11 | Traditional | PDF ↗ |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | 2024-12-02 | Traditional | PDF ↗ |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-11-20 | Traditional | PDF ↗ |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | 2024-10-11 | Traditional | PDF ↗ |
| K240689 | Robin's Egg | Telebrands Corporation | 2024-09-17 | Traditional | PDF ↗ |
| K242441 | Revian Lyte (10011) | Revian, Inc. | 2024-09-13 | Special | PDF ↗ |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2024-05-22 | Special | PDF ↗ |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | 2024-02-07 | Special | PDF ↗ |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | 2023-10-24 | Traditional | PDF ↗ |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-07-31 | Traditional | PDF ↗ |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | 2023-06-23 | Traditional | PDF ↗ |
| K222790 | F65 Laser System | Lumenis Be, Ltd. | 2023-06-14 | Traditional | PDF ↗ |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | 2023-05-23 | Traditional | PDF ↗ |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Wontech Co., Ltd. | 2023-04-28 | Special | PDF ↗ |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023-04-28 | Traditional | PDF ↗ |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07) | Light Tree Ventures Europe B.V. | 2023-04-05 | Traditional | PDF ↗ |
| K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | Xtrallux, LLC | 2022-11-16 | Traditional | PDF ↗ |
| K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022-10-13 | Traditional | PDF ↗ |
| K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022-06-24 | Traditional | PDF ↗ |
| K213027 | Laser Hair Growth Comb | Kam Yuen Plastic Products , Ltd. | 2022-05-26 | Traditional | PDF ↗ |
| K213025 | Laser hair growth helmet | Kam Yuen Plastic Products , Ltd. | 2022-05-12 | Traditional | PDF ↗ |
| K220543 | Auxo A300, A150 and APod | Auxo Hair, LLC | 2022-04-20 | Traditional | PDF ↗ |
| K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. | Shenzhen Cosbeauty Technology Co., Ltd. | 2022-01-19 | Traditional | PDF ↗ |
| K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K211192 | Grivamax Family of Lasers, Models 272 and 148 | Leana Orders, Inc. | 2021-07-20 | Traditional | PDF ↗ |
| K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021-06-29 | Traditional | PDF ↗ |
| K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | 2021-04-16 | Traditional | PDF ↗ |
| K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | Transdermal Cap, Inc. | 2021-03-29 | Traditional | PDF ↗ |
| K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd. | 2020-12-08 | Traditional | PDF ↗ |
| K202983 | easy Hairfull | Y & J Bio Co., Ltd. | 2020-12-08 | Traditional | PDF ↗ |
| K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020-12-03 | Traditional | PDF ↗ |
| K201854 | CAPOGEN Laser Cap | Nature, Inc.redible, Inc. | 2020-09-01 | Traditional | PDF ↗ |
| K200464 | LG Pra. L Derma LD Scalp Care | Lg Electronics.Inc | 2020-07-23 | Traditional | PDF ↗ |
| K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-06-03 | Traditional | PDF ↗ |
| K192552 | Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-04-17 | Traditional | PDF ↗ |
| K193667 | Shapiro MD model laser 272 | Conversion Labs, Pr, LLC | 2020-03-25 | Traditional | PDF ↗ |
| K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2020-01-29 | Special | PDF ↗ |
| K190467 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2019-12-26 | Traditional | PDF ↗ |
| K192627 | Laser Hair Growth Cap | Shang FA Biotechnology Co. | 2019-12-13 | Traditional | PDF ↗ |
| K191754 | Hair Growth System | Kunshan Bella Optical Technology Co., Ltd. | 2019-11-22 | Traditional | PDF ↗ |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Wontech Co., Ltd. | 2019-09-30 | Special | PDF ↗ |
| K192012 | Capillus 112, Capillus 244 | Capillus | 2019-09-12 | Special | PDF ↗ |
| K191154 | Hair Boom 69 | Wontech | 2019-07-29 | Traditional | PDF ↗ |
| K190685 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-07-26 | Traditional | PDF ↗ |
| K183417 | iRestore Professional 282 | Freedom Laser Therapy, Inc. | 2019-05-17 | Traditional | PDF ↗ |
| K183329 | Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity | 2019-01-16 | Traditional | PDF ↗ |
| K182562 | Hair Boom 69 | Wontech | 2018-11-16 | Traditional | PDF ↗ |
| K182501 | Hair Laser Headband | Pulsaderm, LLC | 2018-10-26 | Special | PDF ↗ |
| K181878 | Kiierr 272 Laser, Kiierr 148 Laser | Kiierr International, LLC | 2018-09-05 | Traditional | PDF ↗ |
| K181308 | SuperGrow 272, Ultimate 272 | Super Grow Lasers | 2018-08-15 | Traditional | PDF ↗ |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2018-08-10 | Traditional | PDF ↗ |
| K180885 | HairMax Laser | Lexington International, LLC | 2018-06-20 | Traditional | PDF ↗ |
| K180617 | Hair Up | Y & J Bio Co., Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K180460 | Theradome LH40 | Theradome, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K173846 | DermaScalp Laser Cap | Dermascalp, LLC | 2018-03-21 | Traditional | PDF ↗ |
| K173729 | REVIAN RED | Photonmd, Inc. | 2018-02-28 | Traditional | PDF ↗ |
| K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | 2018-02-28 | Traditional | PDF ↗ |
| K171835 | Irradiation Aesthetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-01-30 | Traditional | PDF ↗ |
| K173843 | illumiflow 148 Laser Cap | Eglobal, LLC | 2018-01-26 | Special | PDF ↗ |
| K171775 | Theradome LH80 PRO | Theradome, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K172968 | Hair Up | Y & J Bio Co., Ltd. | 2018-01-05 | Traditional | PDF ↗ |
| K172982 | SuperGrow 272, Ultimate 272 | Super Grow Lasers | 2017-12-19 | Traditional | PDF ↗ |
| K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | 2017-08-22 | Traditional | PDF ↗ |
| K162782 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2017-04-04 | Traditional | PDF ↗ |
| K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017-02-24 | Traditional | PDF ↗ |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | Capillus, LLC | 2017-01-31 | Traditional | PDF ↗ |
| K162994 | Capillus302, Capillus312, Capillus352 | Capillus, LLC | 2016-11-18 | Special | PDF ↗ |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016-09-30 | Traditional | PDF ↗ |
| K160728 | NutraStim Hair Laser Helmet | Nutra Luxe MD, LLC | 2016-09-16 | Traditional | PDF ↗ |
| K161046 | Laser Helmet LH40-EVO | Theradome, Inc. | 2016-05-12 | Special | PDF ↗ |
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016-04-25 | Traditional | PDF ↗ |
| K152587 | DermaScalp Laser Cap | Dermascalp, LLC | 2016-02-04 | Traditional | PDF ↗ |
| K153618 | Capillus202 | Capillus, LLC | 2016-01-19 | Special | PDF ↗ |
| K151662 | iRestore | Freedom Laser Therapy, Inc. | 2016-01-06 | Traditional | PDF ↗ |
| K152019 | HairMD | Trophy Skin, Inc. | 2015-11-16 | Traditional | PDF ↗ |
| K151516 | Capillus82 | Capillus, LLC | 2015-08-21 | Special | PDF ↗ |
| K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015-07-22 | Traditional | PDF ↗ |
| K150578 | Capillus 272 Office Pro | Capillus, LLC | 2015-06-09 | Traditional | PDF ↗ |
| K142824 | LX-100 Hair Growth Stimulation System | Hairlabs International, Inc. | 2015-04-14 | Traditional | PDF ↗ |
| K143199 | Capillus 272 Pro | Capillus, LLC | 2015-01-29 | Traditional | PDF ↗ |
| K141596 | NUTRA STIM HAIR LASER COMB | Nutra Luxe MD, LLC | 2015-01-08 | Traditional | PDF ↗ |
| K141588 | NUTRA STIM HAIR LASER COMB | Nutra Luxe MD, LLC | 2015-01-08 | Traditional | PDF ↗ |
| K140931 | IGROW II HAIR GROWTH SYSTEM | Apira Science, Inc. | 2014-12-05 | Traditional | PDF ↗ |
Product code OAP · Class II · Physical Medicine. Data: openFDA.