Cynosure SculpSure

SculpSure is Cynosure's non-invasive body contouring laser. FDA's summaries describe a console driving four applicators, each built around semiconductor diodes that emit continuous 1060 nm infrared light to heat the fat layer under the skin. Clearance came in stages: flanks in May 2015 under K150230, abdomen in July 2015 under K150724, then back and thighs in 2017. Cynosure's annual report for 2015 says commercial sales began in the second half of that year. A September 2017 clearance added the submental area under the chin, and a January 2019 clearance, K182741, added a petite mask for narrow jawlines.

Each body applicator treats a 4 by 6 cm area, and they are held against the body with a belt. For the chin, one applicator head sits in a frame strapped on with headgear, using either the standard mask or the petite mask. FDA lists maximum power densities of 1.4 W per square centimeter for body work and 3.06 W per square centimeter for the submental masks. The body indications apply to patients with a BMI of 30 or less, and the submental indication to a BMI of 49 or less. Cynosure gives roughly 25 minutes per treatment area and markets the applicators with contact cooling.

SculpSure needs a Patented Applicator for Contouring, or PAC, to activate each applicator for a treatment cycle. Cynosure sold PACs as keys holding 100 applicator uses, so a working system without PAC credits cannot treat patients. FDA's device database also lists a submental only console, part number 100-7026-910, separate from the full laser assembly, 100-7026-010. Check the label, because a submental only unit is a different machine from a body system.

List each applicator with its part number. Report whether you have the frames, belts, both submental masks and the headgear, and how many uses remain on any PAC keys. A photo of the serial label, the software version and the date of the last service will also be requested,.