# K220970: Renuvion APR Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation (Formerly Bovie Medical Corporation)
- Decided: Jul 15, 2022 after 102 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894762 (1989). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191542: Apyx Plasma/RF Handpiece, Bovie Medical Corporation Dba Apyx Medical Corporation (2019) Summary page 4.

## Most influential descendants
- K223262: Renuvion® APR Handpiece (2023), 2 descendants of its own
- K230272: Renuvion® APR Handpiece (2023), 1 descendant of its own
- K230586: Renuvion® Micro Handpiece (2023), 0 descendants of its own

## Indications for use
Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region. The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).

Source page: https://510kreport.com/device/K220970
Methodology: https://510kreport.com/methodology