510(k) K262885
K262885 is an FDA 510(k) premarket notification submitted by Guangxi Hope Medical Devices Technology Co., Ltd. for the device "308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)". The FDA issued a decision of Substantially Equivalent on Oct 14, 2026. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 14, 2026
- Date Received
- Aug 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type
- 510(k)