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U.S. Department of Health and Human Services

Product Classification

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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 CodePKY
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic 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
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