K253400
- 510(k) number
- K253400
- Device name
- LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
- Applicant
- Shenzhen Saidi Light Therapy Technology Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2025-12-24
- Date received
- 2025-09-30
- 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: K253400.pdf
Official FDA record: K253400
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.