# K250065: DENSITY; DENZA; DENSITY Noir

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical Incorporated
- Decided: Jul 8, 2025 after 179 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: 21 generations back to K943450 (1995). 120 ancestors in all.
No later device cites it as a predicate yet.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230663: Density, Jeisys Medical, Inc. (2023) Summary page 6.

## Indications for use
This device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K250065
Methodology: https://510kreport.com/methodology