# K192185: The Cellfina System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: Oct 9, 2019 after 58 days
- Product code: OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite)
- Device class: 2
- Regulation: 21 CFR 878.4790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN110004 (2013). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161885: The Cellfina System, Ulthera, Inc. (2016) Summary page 4.

## Most influential descendants
- K212399: Aveli (2021), 2 descendants of its own
- K221336: Avéli (2022), 1 descendant of its own
- K232153: Avéli (2023), 0 descendants of its own

## Indications for use
The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.

Source page: https://510kreport.com/device/K192185
Methodology: https://510kreport.com/methodology