510(k) K262285
K262285 is an FDA 510(k) premarket notification submitted by Shijiazhuang Recovery Star Medical Device Co., Ltd. for the device "UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)". The FDA issued a decision of Substantially Equivalent on Oct 5, 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 5, 2026
- Date Received
- Jul 6, 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)