K252414 is an FDA 510(k) clearance for the Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1), a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 30, 2025, 90 days after receiving the submission on August 1, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K252414 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 2025 |
| Decision Date | October 30, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAP — Laser, Comb, Hair |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5500 |
| Definition | Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V |