Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OAP — Predicate Candidate Screening
112 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
234 days90th percentile
112clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK- | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026-07-17 | 57 | 0 |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5 | Ziree Co., Ltd. | 2026-06-26 | 71 | 0 |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F2 | Zdeer Technology (Henan) Co., Ltd. | 2026-06-16 | 90 | 0 |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, L | Hubei Yjt Technology Co.,Ltd | 2026-06-16 | 260 | 0 |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026-06-05 | 368 | 0 |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWT | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-23 | 63 | 0 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | 2025-12-24 | 85 | 0 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-30 | 90 | 0 |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | 2025-10-22 | 89 | 0 |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-17 | 76 | 0 |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | 2025-06-05 | 107 | 0 |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA44 | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-04-29 | 85 | 0 |
| K242747 | FAQ™ (302) | Foreo, Inc. | 2024-12-11 | 90 | 0 |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | 2024-12-02 | 90 | 0 |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-11-20 | 103 | 0 |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-11-08 | 179 | 0 |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | 2024-11-01 | 59 | 0 |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | 2024-10-11 | 234 | 0 |
| K240689 | Robin's Egg | Telebrands Corporation | 2024-09-17 | 188 | 0 |
| K242441 | Revian Lyte (10011) | Revian, Inc. | 2024-09-13 | 28 | 0 |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2024-05-22 | 97 | 0 |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | 2024-02-07 | 29 | 0 |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | 2023-10-24 | 78 | 0 |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-07-31 | 84 | 0 |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | 2023-06-23 | 60 | 0 |
| K222790 | F65 Laser System | Lumenis Be, Ltd. | 2023-06-14 | 272 | 0 |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Laser | Hubei Yjt Technology Co.,Ltd | 2023-05-23 | 126 | 0 |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Wontech Co., Ltd. | 2023-04-28 | 126 | 0 |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023-04-28 | 56 | 0 |
| K230336 | CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) | Light Tree Ventures Europe B.V. | 2023-04-05 | 57 | 0 |
| K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022-11-18 | 94 | 0 |
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA | Xtrallux, LLC | 2022-11-16 | 104 | 0 |
| K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | 2022-10-13 | 90 | 0 |
| K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022-06-24 | 200 | 0 |
| K213027 | Laser Hair Growth Comb | Kam Yuen Plastic Products , Ltd. | 2022-05-26 | 247 | 0 |
| K213025 | Laser hair growth helmet | Kam Yuen Plastic Products , Ltd. | 2022-05-12 | 233 | 0 |
| K220543 | Auxo A300, A150 and APod | Auxo Hair, LLC | 2022-04-20 | 54 | 0 |
| K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 1 | Shenzhen Cosbeauty Technology Co., Ltd. | 2022-01-19 | 86 | 0 |
| K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021-12-22 | 89 | 0 |
| K211192 | Grivamax Family of Lasers, Models 272 and 148 | Leana Orders, Inc. | 2021-07-20 | 90 | 0 |
| K211038 | Biophotas Celluma RESTORE | Biophotas, Inc. | 2021-06-29 | 83 | 0 |
| K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | 2021-04-16 | 84 | 0 |
| K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | Transdermal Cap, Inc. | 2021-03-29 | 90 | 0 |
| K202983 | easy Hairfull | Y & J Bio Co., Ltd. | 2020-12-08 | 69 | 0 |
| K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd. | 2020-12-08 | 88 | 0 |
| K193008 | Tricoglam Home Use | Advihair S.R.L. | 2020-12-03 | 402 | 0 |
| K201854 | CAPOGEN Laser Cap | Nature, Inc.redible, Inc. | 2020-09-01 | 57 | 0 |
| K200464 | LG Pra. L Derma LD Scalp Care | Lg Electronics.Inc | 2020-07-23 | 148 | 0 |
| K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-06-03 | 57 | 0 |
| K192552 | Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-04-17 | 213 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda