Cynosure TempSure Firm

TempSure Firm is the body treatment configuration of Cynosure's TempSure radiofrequency platform. It is not a separate generator. The same 300 W console that runs the TempSure Envi facial handpieces drives the Firm handpieces, which deliver continuous monopolar radiofrequency through a neutral pad placed on the patient. FDA's summaries give the generator's output as a 4.0 MHz sine wave, and a thermistor in the tip of each temperature sensing handpiece reports skin temperature to the screen during treatment. FDA first cleared TempSure under K171262 in September 2017.

Cynosure's product page lists three Firm handpiece sizes from 25 mm to 60 mm, aimed at the abdomen, arms, buttocks and thighs. In FDA's filings these are the 25 mm, 30 mm and 60 mm handpieces. The 60 mm handpiece and its massage head were cleared in July 2019 under K190678, along with a larger disposable neutral pad for body work. FDA clears the 25, 30 and 60 mm handpieces for heating tissue for temporary relief of pain, muscle spasms and increased local circulation. Massage heads in 25, 30 and 60 mm sizes are cleared for temporary reduction in the appearance of cellulite.

Because Firm and Envi share one console, the handpieces in the box tell you what you own. FDA's device database lists a Body Accessory Kit, a separate 60 mm body accessory kit, the 60 mm handpiece and the massage heads, each under its own part number. It also lists the aesthetic system, part 100-7027-010, apart from the system with surgical modes, 100-7027-510. FlexSure applicators, cleared in 2020, are a different single use body accessory for the same generator.

A dealer will ask for a list of every handpiece and massage head by size, and for the condition of each thermistor tip, cable and connector. Note any unopened neutral pads, give the software version and service history, and photograph the label showing the part number along with the main screen.