510(k) clearance
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
- 510(k) number
- K260767
- Applicant
- Kam Yuen Plastic Products , Ltd.
- Decision date
- Aug 31, 2026
- Date received
- Mar 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OHS
- Device type
- Light Based Over The Counter Wrinkle Reduction
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Zhongshan, CN