Definition: For Hand Augmentation To Correct Volume Loss In The Dorsum Of The Hands.
| Device Type ID | 5963 |
| Device Name | Implant, Dermal, For Aesthetic Use In 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PKY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5963 |
| Device | Implant, Dermal, For Aesthetic Use In The Hands |
| Product Code | PKY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 2 |