# K191068: Powersculp laser lipolysis system

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Lotuxs Technology Co., Ltd.
- Decided: Jul 17, 2019 after 86 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: 21 generations back to K943450 (1995). 183 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160470: SculpSure, Cynosure, Inc. (2016) Summary page 4.
- K150230: SculpSure, Cynosure, Inc. (2015) Summary page 4.

## Most influential descendants
- K212331: BodySculp (2021), 1 descendant of its own
- K201731: Diode Laser Body Sculpture System (2020), 1 descendant of its own
- K233099: Gladiator (2024), 0 descendants of its own
- K240658: 1060nm laser body slimming machine (2024), 0 descendants of its own
- K222265: Diosculpt (2022), 0 descendants of its own

## Indications for use
The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

Source page: https://510kreport.com/device/K191068
Methodology: https://510kreport.com/methodology