Cynosure Cellulaze

Cellulaze is a Cynosure laser workstation for a minimally invasive cellulite procedure. It uses a 1440 nm Nd:YAG laser whose energy travels through an optical fiber housed in a cannula that the physician places under the skin, with an integrated temperature monitoring guide. Cynosure launched the Cellulaze workstation in the European community in February 2011, and FDA cleared it under K102541 on January 26, 2012. A second clearance, K123407 in March 2013, covers improvement in the appearance of cellulite supported by long term clinical data. Cynosure's filings later report additional clearances in Argentina, Mexico and Taiwan in 2014.

The system came out of the Smartlipo line. The predicate named in the 2012 clearance is the Smartlipo multiwavelength laser with a 1440 nm wavelength, and Cynosure's annual reports describe Cellulaze as sharing the ThermaGuide temperature delivery system used on Smartlipo workstations. Cynosure calls its fiber SideLight 3D and describes it as side firing. FDA's device identifier database lists a Cellulaze handpiece sold in two packs and a 250 mm ThermaGuide cannula made for Cellulaze.

That family relationship is the main source of confusion for sellers. Smartlipo multiwavelength consoles also carried a 1440 nm laser, and FDA's database lists Smartlipo fibers and cannulas separately from the Cellulaze parts. Read the name on the console label rather than the brochures that came with it, and say which fibers, cannulas and handpieces you have and which model each one is labeled for.

Disposables decide much of what a used Cellulaze can do. Cynosure's filings describe the SideLight 3D fiber as a consumable, so a buyer will want to know how many sealed fibers and cannulas come with the unit and their expiration dates. Beyond that, gather the service history, the temperature guide and its cable, the footswitch, the software version and photos of the console label and main screen.