SGQ — Intraoral Phototherapy Device Class II
FDA product code SGQ covers "Intraoral Phototherapy Device", a Class II medical device regulated under 21 CFR 872.5595. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGQ
- Device Class
- Class II
- Regulation Number
- 872.5595
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240077 | Mureva Phototherapy | MuReva OM | Nov 26, 2025 |