# K121977: Plasmajet Neutral Plasma Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Plasma Surgical Limited
- Decided: Nov 20, 2012 after 138 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 K936109 (1994). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080197: Plasmajet Neutral Plasma Surgery System, Plasma Surgical, Ltd. (2008) Summary page 1.
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003) Summary page 1.
- K100415: Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System, Lumenis (2010) Summary page 1.

## Most influential descendants
- K253917: ARION ARC System (2026), 0 descendants of its own

## Indications for use
The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery. The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.

Source page: https://510kreport.com/device/K121977
Methodology: https://510kreport.com/methodology