K252189
- 510(k) number
- K252189
- Device name
- LED Light Therapy Mask (2311, 2344, 2457, 2458)
- Applicant
- Dongguan Yanxi Technology Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2025-09-12
- Date received
- 2025-07-14
- 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: K252189.pdf
Official FDA record: K252189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.