# K134010: Cabochon System

- Pathway: 510(k) (Traditional)
- Applicant: Cabochon Aesthetics, Inc.
- Decided: Apr 14, 2014 after 105 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: 1 generation back to DEN110004 (2013). 1 ancestor in all.
7 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)
- DEN110004: Cabochon System, Cabochon Aesthetics, Inc. (2013). Our reading of the summary gave K101231, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110004, Cabochon System (Cabochon Aesthetics, Inc.), granted Jul 12, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K150505: Cellfina System (2015), 6 descendants of its own
- 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

## Indications for use
The Cabochon 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 1 year of observation.

Source page: https://510kreport.com/device/K134010
Methodology: https://510kreport.com/methodology