K252414
- 510(k) number
- K252414
- Device name
- Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2025-10-30
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K252414.pdf
Official FDA record: K252414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.