# K191484: Renuvion/J-Plasma Precise Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation (Formerly Bovie Medical Corporation)
- Decided: Jul 30, 2019 after 56 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: 9 generations back to K894762 (1989). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183610: Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces, Bovie Medical Corporation (2019) Summary page 4.
- K151325: Bovie J-Plasma Handpiece, Bovie Medical Corporation (2015) Summary page 4.

## Indications for use
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible 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 Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

Source page: https://510kreport.com/device/K191484
Methodology: https://510kreport.com/methodology