K242363
- 510(k) number
- K242363
- Device name
- HIGHERDOSE Red Light Hat (HG-120K)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2024-11-20
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K242363.pdf
Official FDA record: K242363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.