LightStrike+ (MXSUV1-SL and MXSUV1-FT)
FDA 510(k) clearance DEN230007 · decided 2023-09-01
Clearance details
- K-number
- DEN230007
- Device name
- LightStrike+ (MXSUV1-SL and MXSUV1-FT)
- Applicant
- Xenex Disinfection Services, Inc.
- Decision
- Unknown
- Date received
- 2023-02-01
- Decision date
- 2023-09-01
- Days to decision
- 212 days
- Clearance type
- Direct
- Product code
- QXJ
- Device class
- 2
- Regulation number
- 880.6510
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| Helios+ UV-C System (K242604) | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |
Recalls involving this device
No recalls on record reference this clearance.