Therapeutic devices · 21 CFR 872 Subpart F
Intraoral Phototherapy Device
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.
- Companies listing it
- 22 makers
- Brands and models
- 2
- 510(k) clearances
- 11 in five years
- FDA name
- Intraoral Phototherapy Device
510(k) clearances per year, 1976–2026
Companies that list SGQ
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| MuReva Phototherapy Inc. | United States | Maker | MuReva OM | 1 | 2025 |
| Lumitex Medical Devices, Inc. | United States | Maker | MuReva OM | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 26 Nov 2025 | DEN240077 | MuReva OM | MuReva Phototherapy Inc. |
Official records: FDA product classification for SGQ · 21 CFR 872.5595.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026