# K222265: Diosculpt

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Decided: Sep 23, 2022 after 57 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: 24 generations back to K943450 (1995). 188 ancestors in all.
No later device cites it as a predicate yet.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171992: SculpSure, Cynosure, Inc. (2017) Summary page 4.
- K191068: Powersculp laser lipolysis system, Wuhan Lotuxs Technology Co., Ltd. (2019) Summary page 4.

## Indications for use
The DioSculpt laser system 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.

Source page: https://510kreport.com/device/K222265
Methodology: https://510kreport.com/methodology