K261052
- 510(k) number
- K261052
- Device name
- LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
- Applicant
- Guangdong Newdermo Biotech Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2026-06-29
- Date received
- 2026-03-31
- 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: K261052.pdf
Official FDA record: K261052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.