ODU

Facial Implant

Product code

ODU

Device name

Facial Implant

Device class

Class 2

21 CFR

21 CFR 878.3500

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).