# K221830: Apyx One Console

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation
- Decided: Oct 11, 2022 after 110 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)
- K192867: Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3), Bovie Medical Corporation Dba Apyx Medical Corporation (2019) Summary page 4.

## Indications for use
The Apyx One Console is 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/K221830
Methodology: https://510kreport.com/methodology