MuReva OM™
FDA 510(k) clearance DEN240077 · decided 2025-11-26
Clearance details
- K-number
- DEN240077
- Device name
- MuReva OM™
- Applicant
- Mureva Phototherapy, Inc.
- Decision
- Unknown
- Date received
- 2024-12-23
- Decision date
- 2025-11-26
- Days to decision
- 338 days
- Clearance type
- Direct
- Product code
- SGQ
- Device class
- 2
- Regulation number
- 872.5595
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Strongsville, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.