# DEN240077: MuReva OM™

- Pathway: De Novo (Direct)
- Applicant: Mureva Phototherapy, Inc.
- Decided: Nov 26, 2025 after 338 days
- Product code: SGQ (Intraoral Phototherapy Device)
- Device class: 2
- Regulation: 21 CFR 872.5595
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The MuReva OMTM is intended for use during radiation treatment to lower the severity of oral mucositis and associated complications with radiation induced oral mucositis in adult patients receiving radiation to less than 75% of their oral cavity with or without chemotherapy. This device is prescription use only (Rx only).

Source page: https://510kreport.com/device/DEN240077
Methodology: https://510kreport.com/methodology