# Facial Implant
> **Product code: ODU** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3500
## Classification
- **FDA Product Code:** ODU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.3500
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.

## 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=ODU)
---
*AI Analytics · CC0 1.0*