# K201731: Diode Laser Body Sculpture System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Sep 10, 2020 after 78 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). 191 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 193 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.
- K191068: Powersculp laser lipolysis system, Wuhan Lotuxs Technology Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K240658: 1060nm laser body slimming machine (2024), 0 descendants of its own

## Indications for use
The Diode Laser Body Sculpture Systems 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/K201731
Methodology: https://510kreport.com/methodology