# K183610: Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Mar 12, 2019 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894762 (1989). 21 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151325: Bovie J-Plasma Handpiece, Bovie Medical Corporation (2015) Summary page 4.
- K170188: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator, Bovie Medical Corporation (2017) Summary page 4.

## Most influential descendants
- K191542: Apyx Plasma/RF Handpiece (2019), 4 descendants of its own
- K220970: Renuvion APR Handpiece (2022), 3 descendants of its own
- 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

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2060-2020: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

## Indications for use
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.

Source page: https://510kreport.com/device/K183610
Methodology: https://510kreport.com/methodology