Last synced on 2 December 2022 at 11:04 pm

Facial Implant

Page Type
Product Code
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.
Physical State
Solid implants
Technical Method
Plastic surgery
Target Area
face
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

(b) Classification. Class II.

Facial Implant

Page Type
Product Code
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.
Physical State
Solid implants
Technical Method
Plastic surgery
Target Area
face
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

(b) Classification. Class II.