# K230586: Renuvion® Micro Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation
- Decided: Jun 9, 2023 after 99 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: 13 generations back to K894762 (1989). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223262: Renuvion® APR Handpiece, Apyx Medical Corporation (2023) Summary page 4.
- K230272: Renuvion® APR Handpiece, Apyx Medical Corporation (2023). Cleared while this submission was under review Summary page 4.

## Indications for use
Renuvion® Micro Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. The Renuvion® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.

Source page: https://510kreport.com/device/K230586
Methodology: https://510kreport.com/methodology