# K171992: SculpSure

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 26, 2017 after 85 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: 23 generations back to K943450 (1995). 186 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171111: Sculpsure, Cynosure, Inc. (2017) Summary page 4.
- K162050: ZELTIQ CoolSculpting System, Zeltiq Aesthetics, Inc. (2016) Summary page 4.

## Most influential descendants
- K182741: SculpSure (2019), 5 descendants of its own
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K201731: Diode Laser Body Sculpture System (2020), 1 descendant of its own
- K252845: Venus Nova (FP-2001) (2025), 0 descendants of its own
- K240658: 1060nm laser body slimming machine (2024), 0 descendants of its own

## Indications for use
The Cynosure SculpSure™ 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. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.

Source page: https://510kreport.com/device/K171992
Methodology: https://510kreport.com/methodology