# Intraoral Phototherapy Device
> **Product code: SGQ** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5595
## Classification
- **FDA Product Code:** SGQ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5595
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SGQ)
---
*AI Analytics · CC0 1.0*