510(k) DEN240077
- Device
- MuReva OM
- Applicant
- Mureva Phototherapy, Inc.
- 510(k) number
- DEN240077
- Product code
- SGQ
- Decision
- Unknown (DENG)
- Decision date
- 2025-11-26
- Date received
- 2024-12-23
- Regulation
- 872.5595
- Classification name
- Intraoral Phototherapy Device
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Vedang Kothari
- Address
- 8300 Dow Cir. Suite 500 Strongsville OH US 44136 44136
Source Documents
510(k) summary PDF not indicated by FDA