Hair Regrowth Cap (Model: T-119-HRC)
FDA 510(k) K253349 · Light Tree Ventures Europe B.V.
510(k) numberK253349
Submission
- Device name
- Hair Regrowth Cap (Model: T-119-HRC)
- Applicant
- Light Tree Ventures Europe B.V.
Den Haag, NL - Received
- September 30, 2025
- Decision date
- December 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Other 510(k)s with product code OAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120…OAP · Traditional | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 07/17/2026SE |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional | Ziree Co., Ltd. | 06/26/2026SE |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…OAP · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/16/2026SE |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 06/16/2026SE |
| K251684 | Alma TED+ SystemOAP · Traditional | Alma Lasers, Inc. | 06/05/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 01/23/2026SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 06/17/2025SE |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK)OAP · Traditional | Shenzhen Idea Light Limited | 06/05/2025SE |
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| K260415 | myLEDmask 2 (MJ-144)OHS · Traditional | 05/12/2026SE |
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| K223893 | Infrared Heat (Model: E0221)OHS · Traditional | 05/16/2023SE |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)OAP · Traditional | 04/28/2023SE |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)OHS · Traditional | 04/28/2023SE |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07)OAP · Traditional | 04/05/2023SE |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)OHS · Traditional | 03/15/2023SE |
| K223642 | LED Lip Perfector, model: ZC-05ILY · Traditional | 03/09/2023SE |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)OHS · Traditional | 12/20/2022SE |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36BOHS · Traditional | 12/08/2022SE |
Questions and answers
When was Hair Regrowth Cap (Model: T-119-HRC) cleared by the FDA?
Hair Regrowth Cap (Model: T-119-HRC) (K253349) received a 510(k) decision of Substantially Equivalent on December 24, 2025, 85 days after the submission was received.
What is the product code of K253349?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.