# K181896: LIPOcel

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Oct 18, 2019 after 459 days
- Product code: OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption)
- Device class: 2
- Regulation: 21 CFR 878.4590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN080006 (2009). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112626: Lipsonix (R) System Model 2, Medicis Technologies Corporation (2011) Summary page 4.

## Most influential descendants
- K231628: BeShape One™ Device (2023), 0 descendants of its own

## Indications for use
The LIPOcel delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LIPOcel is specifically indicated for non-invasive waist circumference reduction.

Source page: https://510kreport.com/device/K181896
Methodology: https://510kreport.com/methodology