# K222958: mJOULE RF System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Apr 23, 2024 after 574 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: 20 generations back to K943450 (1995). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192545: Potenza, Jeisys Medical Incorporated (2020) Summary page 4.

## Indications for use
The mJOULE RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K222958
Methodology: https://510kreport.com/methodology