InMode Evolve

Evolve was InMode's first hands-free body platform. Instead of a handpiece moved by an operator, it uses applicators secured to the body with belts, and the console runs the session. The FDA cleared the system under the name EmBody on June 20, 2019 (K183450), and InMode's 2019 annual report says Evolve reached the market in the second half of that year.

Three applicator sets define the platform. Tite, listed as EmBodyPlus in the clearance, uses up to eight RF applicators at once. Trim, listed as EmBodyFX, uses up to six applicators that combine RF with vacuum massage, at a vacuum range of 200 to 500 mbar. Both run at 1 MHz with up to 50 W of output, and the clearance names an automatic temperature cut off between 35 and 43 degrees Celsius. Tone, a set of four electrical muscle stimulation applicators, was added through a separate clearance (K192249, December 2019) that covers EMS and TENS modes.

InMode states that EvolveX, cleared in 2021, replaced Evolve. The quickest way to tell them apart is the applicator set: EvolveX introduced Transform, six applicators that alternate RF and muscle stimulation, while Trim belongs to the original Evolve. If the applicators have been mixed between systems, the serial label settles the question.

Because Evolve is no longer sold new, a buyer will want to know exactly which applicator sets are in the box and how many of each, since a full Tite set is eight pieces and a full Trim set is six. The 510(k) describes the treatment belts as single use, so mention any spare belts. Expect questions about vacuum performance on the Trim applicators, cable wear, software version and the date of the last service. Photos of the serial label, the screen and each applicator set help a dealer make an offer.