# K142975: Bovie Ultimate High Frequency Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation
- Decided: Dec 12, 2014 after 59 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: 5 generations back to K933002 (1994). 16 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator, Bovie Medical Corporation (2014) Summary page 4.
- K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC), Bovie Medical (2009) Summary page 4.

## 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

## Indications for use
The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces

Source page: https://510kreport.com/device/K142975
Methodology: https://510kreport.com/methodology