Product code SGQ
- Device name
- Intraoral Phototherapy Device
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5595
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN240077 | MuReva OM™ | Mureva Phototherapy, Inc. | 2025-11-26 |