De Novo
DEN240077: MuReva OM™
FDA De Novo · mureva phototherapy, inc. · decided Nov 26, 2025
Key facts
| De Novo number | DEN240077 |
|---|---|
| Device name | MuReva OM™ |
| Applicant | mureva phototherapy, inc. |
| Product code | SGQ |
| Date received | Dec 23, 2024 |
| Decision date | Nov 26, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Dental |
| FEI number | 3045323553 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: