K250581
- 510(k) number
- K250581
- Device name
- KALA Red Light Face Mask (KALA-01)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2025-05-30
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250581.pdf
Official FDA record: K250581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.