DEN240077 is an FDA 510(k) submission for the MuReva OM™. This device is classified as a Intraoral Phototherapy Device (Class II - Special Controls, product code SGQ).
Submitted by Mureva Phototherapy, Inc. (Strongsville, US). The FDA issued a Not Cleared (DENG) decision on November 26, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5595. 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..
| 510(k) Number | DEN240077 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 23, 2024 |
| Decision Date | November 26, 2025 |
| Days to Decision | 338 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | SGQ - Intraoral Phototherapy Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5595 |
| 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. |