K260946
- 510(k) number
- K260946
- Device name
- LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
- Applicant
- Guangdong Newdermo Biotech Co., Ltd. CN
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2026-06-18
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K260946.pdf
Official FDA record: K260946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.