Clearance Summary
MuReva OM received FDA 510(k) clearance under submission number DEN240077, sponsored by Mureva Phototherapy, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-11-26.
- Submission: DEN240077
- Applicant / Sponsor: Mureva Phototherapy, Inc.
- Clearance pathway: Direct
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5595
- Decision date: 2025-11-26
Classification & Regulation
This clearance is catalogued under FDA product code SGQ and 21 CFR 872.5595, within the Dental review panel as a Class II device.