# K083795: Cynosure Smartlipo MPX Laser

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Jan 21, 2009 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cynosure YAG Family laser: named in the summary without a submission number

## Most influential descendants
- K150724: SculpSure (2015), 21 descendants of its own
- K150230: SculpSure (2015), 21 descendants of its own
- K160470: SculpSure (2016), 20 descendants of its own
- K171111: Sculpsure (2017), 10 descendants of its own
- K171992: SculpSure (2017), 8 descendants of its own

## Indications for use
The Cynosure Smartlipo MPX Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo MPX Laser is further indicated for laser assisted lipolysis

Source page: https://510kreport.com/device/K083795
Methodology: https://510kreport.com/methodology