# K201685: Potenza

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Jan 19, 2021 after 211 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.
9 later devices descend from it; 4 cite it directly.
0 of 272 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.

## Most influential descendants
- K231216: Potenza (2024), 4 descendants of its own
- K242469: RFMagik Lite (2025), 2 descendants of its own
- K243176: BLESSING System (2025), 1 descendant of its own
- K231287: Potenza (2024), 1 descendant of its own
- K254185: Potenza Prime (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K201685
Methodology: https://510kreport.com/methodology