# K192545: Potenza

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical Incorporated
- Decided: Feb 20, 2020 after 157 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: 19 generations back to K943450 (1995). 261 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 282 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System, Jeisys Medical, Inc. (2016) Summary page 4.
- K180189: InMode System with Fractora3D/3D-90 Applicators, Inmode MD, Ltd. (2018) Summary page 4.

## Most influential descendants
- K201685: Potenza (2021), 9 descendants of its own
- K231216: Potenza (2024), 4 descendants of its own
- K201735: PlaDuo System (2020), 3 descendants of its own
- K242469: RFMagik Lite (2025), 2 descendants of its own
- K243176: BLESSING System (2025), 1 descendant 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/K192545
Methodology: https://510kreport.com/methodology