DeviceClearance

Product code ODU— General, Plastic Surgery

PERMA FACIAL IMPLANTS

Classification name
Facial Implant
Device class
Class 2
Regulation
21 CFR 878.3500
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ODU under 21 CFR 878.3500, via openFDA

Market context for product code ODU

FDA has cleared 1 device under product code ODU, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ODU

Recent clearances under product code ODU

Data sourced from openFDA. This site is unofficial and independent of the FDA.