# K192867: Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corporation Dba Apyx Medical Corporation
- Decided: Oct 31, 2019 after 24 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: 8 generations back to K894762 (1989). 21 ancestors in all.
1 later device descends from it; 1 cites 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)
- 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
- K221830: Apyx One Console (2022), 0 descendants of its own

## Indications for use
The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

Source page: https://510kreport.com/device/K192867
Methodology: https://510kreport.com/methodology