| Device |
facial implant |
| Regulation Description |
Polytetrafluoroethylene with carbon fibers composite implant material. |
| 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 & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | ODU |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
