Implant, Dermal, For Aesthetic Use In The Hands
The Implant, Dermal, For Aesthetic Use In The Hands (product code PKY) is a Class 3 general and plastic surgery device intended for hand augmentation to correct volume loss in the dorsum of the hands. Class 3 classification requires Premarket Approval (PMA), the most stringent FDA pathway, reflecting the higher risk associated with implantable aesthetic devices. The device is flagged as an implant and has no regulation number assigned.
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Basic Information
- Product Code
- PKY
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 2
Device Characteristics
Definition
For hand augmentation to correct volume loss in the dorsum of the hands.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.