510(k) DEN240077

MuReva OM by Mureva Phototherapy, Inc. — Product Code SGQ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: November 26, 2025
Date Received: December 23, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intraoral Phototherapy Device
Device Class: Class II
Regulation Number: 872.5595
Review Panel: DE
Submission Type

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.