# K240297: Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

- Pathway: 510(k) (Traditional)
- Applicant: Us Medical Innovations, LLC
- Decided: May 3, 2024 after 92 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- 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: 6 generations back to K894762 (1989). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192124: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories, Us Medical Innovations, LLC (2019) Summary page 5.

## Indications for use
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.

Source page: https://510kreport.com/device/K240297
Methodology: https://510kreport.com/methodology