Cutera truSculpt 3D

The truSculpt 3D is a radiofrequency body system that Cutera introduced in May 2017, according to its annual report for that year. It belongs to the truSculpt line Cutera started in 2012, and it delivers energy at 2 MHz to heat subcutaneous tissue. FDA's June 2018 clearance K180709 covers the truSculpt RF Device under the trade names truSculpt and truSculpt 3D. That summary describes RF at 1 MHz and 2 MHz.

A complete system has a console, one or more RF handpieces on umbilical cables, and a truGlide mechanical massage roller. The handpieces carry redundant temperature sensors and track epidermal temperature while the console adjusts power to reach and hold the set temperature. Cutera's 2017 report says the 3D ships with two handpieces, 40 cm2 for larger areas and 16 cm2 for smaller ones. The 510(k) clears the RF heating for relief of minor aches, pain and muscle spasm and for increased local circulation. It clears the 2 MHz setting on the 40 cm2 handpiece for reducing abdominal circumference and for non-invasive lipolysis of the abdomen, and the truGlide roller for temporary reduction in the appearance of cellulite.

Several truSculpt systems look alike. The 3D is operated by hand, with the provider moving the handpiece. The truSculpt iD, launched in July 2018, is a hands-free version that also runs at 2 MHz and uses consumable treatment cycles, and the later truSculpt flex is a different product again. Check the model name on the console label.

On the 3D, handpieces wear out by design. Cutera's filings say each handpiece has to be refilled after a set number of treatments, and Cutera accounts for refills of legacy truSculpt handpieces as service revenue. A buyer will ask how many treatments remain on each handpiece and whether Cutera will still refill them, and will want the truGlide roller, cables, software version and service history accounted for.