# K231628: BeShape One™ Device

- Pathway: 510(k) (Traditional)
- Applicant: Beshape Technologies, Ltd.
- Decided: Sep 29, 2023 after 116 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: 4 generations back to DEN080006 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181896: LIPOcel, Jeisys Medical, Inc. (2019) Summary page 5.

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

Source page: https://510kreport.com/device/K231628
Methodology: https://510kreport.com/methodology