# K230663: Density

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Aug 14, 2023 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: 20 generations back to K943450 (1995). 119 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170758: Thermage FLX System and Accessories, Solta Medical (2017) Summary page 6.

## Most influential descendants
- K250065: DENSITY; DENZA; DENSITY Noir (2025), 0 descendants of its own
- K240897: Cellinew (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K230663
Methodology: https://510kreport.com/methodology