# K080197: Plasmajet Neutral Plasma Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Plasma Surgical, Ltd.
- Decided: Jun 24, 2008 after 151 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121977: Plasmajet Neutral Plasma Surgery System (2012), 1 descendant of its own
- K253917: ARION ARC System (2026), 0 descendants of its own

## Recalls of this device
- Apr 27, 2012 · Class II · Z-1794-2012: Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

Source page: https://510kreport.com/device/K080197
Methodology: https://510kreport.com/methodology