510(k) K251354
K251354 is an FDA 510(k) premarket notification submitted by UV Smart Technologies B.V. for the device "UV Smart D60". The FDA issued a decision of Substantially Equivalent on Jan 29, 2026. The device falls under product code SCS (Ultraviolet Radiation Disinfection Chamber Device), a Class II device regulated under 21 CFR 880.6511.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 29, 2026
- Date Received
- Apr 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultraviolet Radiation Disinfection Chamber Device
- Device Class
- Class II
- Regulation Number
- 880.6511
- Review Panel
- HO
- Submission Type
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.