# K202880: J-Plasma Precise FLEX Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation (Formerly Bovie Medical Corporation
- Decided: Jan 4, 2021 after 98 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: 10 generations back to K953074 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170777: Bovie J-Plasma Precise FLEX Handpiece, Bovie Medical Corporation (2017) Summary page 4.

## Indications for use
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

Source page: https://510kreport.com/device/K202880
Methodology: https://510kreport.com/methodology