# K160470: SculpSure

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jul 21, 2016 after 153 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: 20 generations back to K943450 (1995). 182 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150724: SculpSure, Cynosure, Inc. (2015) Summary page 6.
- K150230: SculpSure, Cynosure, Inc. (2015) Summary page 6.
- K151179: ZELTIQ CoolSculpting System, Zeltiq Aesthetics, Inc. (2015) Summary page 6.

## Most influential descendants
- K171111: Sculpsure (2017), 10 descendants of its own
- K171992: SculpSure (2017), 8 descendants of its own
- K191068: Powersculp laser lipolysis system (2019), 6 descendants of its own
- K182741: SculpSure (2019), 5 descendants of its own
- K190743: Venus Bliss (2019), 4 descendants of its own

## Indications for use
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks 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 and flanks.

Source page: https://510kreport.com/device/K160470
Methodology: https://510kreport.com/methodology