Device |
implant, dermal, for aesthetic use in the hands |
Definition |
For hand augmentation to correct volume loss in the dorsum of the hands. |
Physical State |
Injectable mixture in a syringe with a needle. |
Technical Method |
To provide volume fullness to the dorsum (back) of the hand |
Target Area |
Dorsum (back) of the hand |
Review Panel |
General & Plastic Surgery |
Product Code | PKY |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |