Venus Concept Gets FDA Clearance for New Indications of Its BlissMAX

Venus Concept has received a 510(k) marketing clearance from the FDA for an expanded indication of its Venus BlissMAX lipolysis system.

The expanded clearance allows for use of the noninvasive device for the back and thighs in individuals with a body mass index of 30 or less. The original BlissMAX clearance was for use on the abdomen and flanks. The new indication also allows for a 50 percent increase in radiofrequency energy output.

The BlissMAX device provides laser fat reduction, cellulite reduction and muscle conditioning in a single workstation, according to the Toronto, Canada-based company, which is adding the new indication in its marketing of the subscription-based product in the U.S.