# K091169: Elite MPX Laser System with Cryo C

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: May 13, 2009 after 21 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 9, 2014 · Class II · Z-0169-2015: If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock

Source page: https://510kreport.com/device/K091169
Methodology: https://510kreport.com/methodology