# K150230: SculpSure

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: May 15, 2015 after 102 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: 18 generations back to K943450 (1995). 178 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133212: Zeltiq Coolsculpting System, Zeltiq Aesthetics, Inc. (2014) Summary page 4.
- K083795: Cynosure Smartlipo MPX Laser, Cynosure, Inc. (2009) Summary page 4.
- K123971: Cynosure 1064NM Diode Laser, Cynosure, Inc. (2013) Summary page 4.

## Most influential descendants
- K160470: SculpSure (2016), 20 descendants of its own
- 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

## Indications for use
The Cynosure SculpSure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.

Source page: https://510kreport.com/device/K150230
Methodology: https://510kreport.com/methodology