510(k) clearance
Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)
- 510(k) number
- K262984
- Applicant
- Shenzhen Bway Tech Co., Ltd.
- Decision date
- Oct 26, 2026
- Date received
- Aug 27, 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
- Shenzhen, CN