K250830
- 510(k) number
- K250830
- Device name
- LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
- Applicant
- Shenzhen Sungrow Led Technology Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2025-06-09
- Date received
- 2025-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250830.pdf
Official FDA record: K250830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.