# K152570: Bovie J-Plasma Precise 360 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Nov 2, 2015 after 54 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894762 (1989). 10 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 23 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 5.

## Most influential descendants
- K170188: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator (2017), 11 descendants of its own
- K183610: Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces (2019), 6 descendants of its own
- 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

## Recalls of this device
- Jun 18, 2018 · Class II · Z-0198-2019: There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.
- Jul 18, 2016 · Class II · Z-2646-2016: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
- Jul 18, 2016 · Class II · Z-2648-2016: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
- Jul 18, 2016 · Class II · Z-2647-2016: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
- Jul 18, 2016 · Class II · Z-2649-2016: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

## Indications for use
The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures. The Bovie J-Plasma Precise 360 Handpiece is compatible only with Bovie J-Plasma generators.

Source page: https://510kreport.com/device/K152570
Methodology: https://510kreport.com/methodology