# K091537: Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 3, 2009 after 100 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.
40 later devices descend from it; 2 cite it directly.
0 of 41 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 Smartlipo Multiwavelength Laser: named in the summary without a submission number

## Most influential descendants
- K102541: Cynosure Cellulaze Laser (2012), 39 descendants of its own
- K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers (2012), 25 descendants of its own
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K201801: Rapid Acoustic Pulse Device (2021), 12 descendants of its own

## Indications for use
The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength 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 Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K091537
Methodology: https://510kreport.com/methodology