FDA product code PKY: Implant, Dermal, For Aesthetic Use In The Hands

PKY is the FDA product code for implant, dermal, for aesthetic use in the hands. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under PKY reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.

Definition

For hand augmentation to correct volume loss in the dorsum of the hands.

Classification

Recalls for PKY devices

openFDA lists no recalls for product code PKY.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• L8616 — Microphone for use with cochlear implant device, replacement
• L8617 — Transmitting coil for use with cochlear implant device, replacement
• L8615 — Headset/headpiece for use with cochlear implant device, replacement
• L8629 — Transmitting coil and cable, integrated, for use with cochlear implant device, replacement
• L8622 — Alkaline battery for use with cochlear implant device, any size, replacement, each

Frequently asked questions

What is FDA product code PKY?

PKY is the FDA product code for implant, dermal, for aesthetic use in the hands. It is a Class III device, reviewed by the General and Plastic Surgery panel.

What device class is PKY?

Class III. Typical premarket route: PMA.

Next steps

• Run an FDA pathway report with predicate devices for product code PKY
• Run a recall and safety report across every PKY manufacturer
• Watch product code PKY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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