# K254185: Potenza Prime

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical Incorporated
- Decided: Sep 11, 2026 after 262 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: 22 generations back to K943450 (1995). 265 ancestors in all.
No later device cites it as a predicate yet.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231216: Potenza, Jeisys Medical, Inc. (2024) Summary page 5.
- K231287: Potenza, Jeisys Medical, Inc. (2024). Our reading of the summary gave K231286, FDA’s number for Chemfort® Catheter Adaptor (Simplivia Healthcare, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Potenza”. Summary page 11.

## Indications for use
The Potenza Prime is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, the DDR tips are limited to Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K254185
Methodology: https://510kreport.com/methodology