# K150505: Cellfina System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: Jul 29, 2015 after 154 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: 2 generations back to DEN110004 (2013). 2 ancestors in all.
6 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)
- K134010: Cabochon System, Cabochon Aesthetics, Inc. (2014) Summary page 4.

## Most influential descendants
- K153677: The Cellfina System (2016), 5 descendants of its own
- K161885: The Cellfina System (2016), 4 descendants of its own
- K192185: The Cellfina System (2019), 3 descendants of its own
- K212399: Aveli (2021), 2 descendants of its own
- K221336: Avéli (2022), 1 descendant 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 up to 2 years of observation.

Source page: https://510kreport.com/device/K150505
Methodology: https://510kreport.com/methodology