SculpSure submental application now FDA-cleared for patients with BMI up to 49.

Hologic’s Cynosure division is rolling out the TempSure® Firm handpiece and a petite mask for WarmSculpting with SculpSure® Profile treatments.

What's more, the company also announced SculpSure submental treatments are now cleared by the US Food and Drug Administration for patients with a BMI up to 49 — the highest BMI clearance on the market for submental treatments.

 The TempSure Firm handpiece, created for use with the existing TempSure platform, uses monopolar radiofrequency energy to gently heat tissue and temporarily reduce the appearance of cellulite with unique massage heads. The new 60mm handpiece allows practitioners to treat larger areas of the body such as the abdomen, arms, buttocks and thighs at a faster rate, without surgery or downtime.

Cynosure’s new petite mask attachment to the SculpSure platform will allow practitioners to perform WarmSculpting™ Profile treatments of submental fat on patients with a narrow jawline.

"The WarmSculpting Profile treatment was already a game-changer for addressing the double chin, and after listening to customer feedback, we are excited to introduce the petite mask — the latest evolution of the cutting-edge SculpSure device,” says Erik Anderson, Hologic’s Division President, Cynosure, in a news release. “Our clinicians tell us almost 20 percent of their patients have smaller, narrow jawlines, and with the new petite mask, they can help even more men and women feel their best with non-surgical fat reduction in that area. The updated BMI clearance of 49 for all submental treatments is a clear competitive advantage and underscores our market-leader status in the body contouring category.”

 “The TempSure Firm handpiece enhances the functionality and versatility of our already cutting-edge TempSure radiofrequency platform,” he adds. “The larger 60 mm handpiece allows practitioners to further expand and differentiate their practices, while treating more patients seeking to temporarily reduce the appearance of cellulite. These launches are prime examples of the continuous innovation we are committed to in order to best serve our patients and providers.”

 “The new offerings from Cynosure allow practitioners to meet the growing patient demand in the expanding arena of body contouring,” says Dr. Raminder Saluja of Saluja Cosmetic and Laser Center Huntersville, NC. “TempSure Firm allows me to confidently, and now more quickly, address patient needs and deliver results they’re looking for.  WarmSculpting Profile treatments with SculpSure are my go-to option for patients looking for noticeable results without surgery, and now with the expanded BMI clearance and petite mask, I can treat those who might not have been candidates before.”

In conjunction with these launches, Cynosure has updated its SculpSure software to include a new, optional, guided mode feature. It comprises a preset algorithm for energy titration, resulting in a controlled increase in temperature to achieve lipolysis, as well as energy setting parameters designed to guide providers into a repeatable and comfortable treatment for their patients.