# K161636: Lipogems System

- Pathway: 510(k) (Traditional)
- Applicant: Lipogems International Spa
- Decided: Nov 4, 2016 after 143 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: 9 generations back to K910696 (1991). 29 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K142682: The Lipogems System, Lipogems International Spa (2014) Summary page 4.

## Most influential descendants
- 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
- K182732: JTL-250-01 (2019), 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 in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

Source page: https://510kreport.com/device/K161636
Methodology: https://510kreport.com/methodology