UV Smart D60
FDA 510(k) clearance K251354 · decided 2026-01-29
Clearance details
- K-number
- K251354
- Device name
- UV Smart D60
- Applicant
- UV Smart Technologies B.V.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-30
- Decision date
- 2026-01-29
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- SCS
- Device class
- 2
- Regulation number
- 880.6511
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rijswijk, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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| Chronos® (DEN230067) | Germitec | 2024-08-28 |
Recalls involving this device
No recalls on record reference this clearance.