510(k) DEN240077
DEN240077 is an FDA 510(k) premarket notification submitted by Mureva Phototherapy, Inc. for the device "MuReva OM". The FDA issued a decision of De Novo Granted on Nov 26, 2025. The device falls under product code SGQ (Intraoral Phototherapy Device), a Class II device regulated under 21 CFR 872.5595.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Nov 26, 2025
- Date Received
- Dec 23, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoral Phototherapy Device
- Device Class
- Class II
- Regulation Number
- 872.5595
- Review Panel
- DE
- Submission Type
An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis.