510(k) K262984
K262984 is an FDA 510(k) premarket notification submitted by Shenzhen Bway Tech Co., Ltd. for the device "Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)". The FDA issued a decision of Substantially Equivalent on Oct 26, 2026. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2026
- Date Received
- Aug 27, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
- 510(k)
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.