SGQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intraoral Phototherapy Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5595
- Medical specialty
- Dental
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| MuReva OM™ (DEN240077) | Mureva Phototherapy, Inc. | 2025-11-26 |
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