Helios+ UV-C System
FDA 510(k) clearance K242604 · decided 2025-05-27
Clearance details
- K-number
- K242604
- Device name
- Helios+ UV-C System
- Applicant
- Preventamed Technologies, Inc. Dba Surfacide Manufacturing
- Decision
- Substantially Equivalent
- Date received
- 2024-08-30
- Decision date
- 2025-05-27
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- QXJ
- Device class
- 2
- Regulation number
- 880.6510
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waukesha, WI, US
- 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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|---|---|---|
| LightStrike+ (MXSUV1-SL and MXSUV1-FT) (DEN230007) | Xenex Disinfection Services, Inc. | 2023-09-01 |
Recalls involving this device
No recalls on record reference this clearance.