ODU

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Facial Implant

Device class

Class II (moderate risk)

Regulation

21 CFR 878.3500

Medical specialty

General, Plastic Surgery

Flags

Implant

FDA 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.

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