Thermi, a leader in thermistor-regulated energy solutions for plastic surgery and dermatology, has announced the U.S. Food and Drug Administration (FDA) clearance of Thermi250 for the temporary reduction of cellulite. Thermi250 represents a high-powered addition to the company’s portfolio of temperature controlled radiofrequency devices, providing a myriad of solutions to the aesthetic medical marketplace.
The Thermi250 is a high-powered, thermistor-regulated radiofrequency system designed with a wide array of electrodes and a user-friendly graphic interface. The Thermi250 treatment, known as ThermiSmooth, helps clients concerned with skin laxity and localized unwanted fat as associated with cellulite. “ThermiSmooth is expected to become a go-to solution for patients who are seeking non-surgical solutions to common aesthetic problems,” says president, Kevin O’Brien. “The versatility of the Thermi250 device will ensure that ThermiSmooth treatments will produce predictable results and a high profit revenue source for plastic surgeons and dermatologists.”
A multi-site IRB approved clinical study was conducted in more than 90 sites across the U.S. to determine the range of efficacy and safety for a range of conditions such as wrinkles, skin laxity, body slimming and cellulite. The first data from the study appeared in the November 2015 issue of the Journal of Drugs in Dermatology. The study documented the positive results of 14 patients treated for abdominal laxity who received four treatments at two week intervals, and concluded that the device “is a safe and effective modality for noninvasive body slimming.” The company plans to conduct further studies related to the reduction of unwanted localized fat and other skin conditions.