K241933
- 510(k) number
- K241933
- Device name
- HIGHERDOSE Red and Infrared Light Mask (MK66-L)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2024-09-27
- Date received
- 2024-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K241933.pdf
Official FDA record: K241933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.