# K231131: Diode Laser Body Sculpture Systems

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Bele Medical Technology Co.,Ltd
- Decided: Jun 22, 2023 after 62 days
- Product code: PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 190 ancestors in all.
No later device cites it as a predicate yet.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182741: SculpSure, Cynosure (2019) Summary page 4.

## Indications for use
This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

Source page: https://510kreport.com/device/K231131
Methodology: https://510kreport.com/methodology