# K182741: SculpSure

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure
- Decided: Jan 3, 2019 after 97 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). 189 ancestors in all.
5 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)
- K171992: SculpSure, Cynosure, Inc. (2017) Summary page 4.
- K172144: CoolSculpting System, Zeltiq Aesthetics (2017) Summary page 4.

## Most influential descendants
- 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
- K231131: Diode Laser Body Sculpture Systems (2023), 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 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.

Source page: https://510kreport.com/device/K182741
Methodology: https://510kreport.com/methodology