# K142682: The Lipogems System

- Pathway: 510(k) (Traditional)
- Applicant: Lipogems International Spa
- Decided: Dec 22, 2014 after 94 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910696 (1991). 28 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120902: GID 700, The Gid Group, Inc. (2012) Summary page 6.

## Most influential descendants
- K161636: Lipogems System (2016), 5 descendants of its own
- K171135: Lipogems System (2017), 2 descendants of its own
- K193363: Dermapose Refresh (2020), 1 descendant of its own
- K210528: IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (2022), 0 descendants of its own
- K202443: Smart Kit Basic, Smart Kit Pro (2021), 0 descendants of its own

## Indications for use
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.

Source page: https://510kreport.com/device/K142682
Methodology: https://510kreport.com/methodology