K250880
- 510(k) number
- K250880
- Device name
- LED LIGHT MASK (A093)
- Applicant
- Foshan Guangyu Weilai Medical Equipment Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2025-06-20
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250880.pdf
Official FDA record: K250880
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.