ODU — Facial Implant Class II
FDA product code ODU covers "Facial Implant", a Class II medical device regulated under 21 CFR 878.3500. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ODU
- Device Class
- Class II
- Regulation Number
- 878.3500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071823 | surgisil | PERMA FACIAL IMPLANTS | September 19, 2007 |