# K151325: Bovie J-Plasma Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Aug 4, 2015 after 78 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: 5 generations back to K894762 (1989). 9 ancestors in all.
13 later devices descend from it; 6 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)
- K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade, Bovie Medical Corporation (2012) Summary page 4.

## Most influential descendants
- K152570: Bovie J-Plasma Precise 360 Handpiece (2015), 12 descendants of its own
- 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

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2061-2020: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

## Indications for use
The Bovie J-Plasma 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 Handpiece is compatible only with Bovie J-Plasma generators.

Source page: https://510kreport.com/device/K151325
Methodology: https://510kreport.com/methodology