SculpSure has announced some exciting news. The popular fat-melting procedure, which is offered by Dr. Nicole Hayre at Cosmetic Dermatology Center, has received 510K clearance to market from the U.S. Food and Drug Administration (FDA) for the treatment of the back, inner thighs, and outer thighs.
As SculpSure is already FDA-cleared for the treatment of the abdomen and flanks, the groundbreaking body contouring procedure can now treat five different body areas.
Prospective, controlled studies were conducted by Cynosure at three study centers to evaluate the safety and efficacy of the SculpSure laser.
The study included 168 subjects, with a total of 214 treatment areas, and was conducted in the same manner as previous abdomen and flank studies. Treatment effectiveness was assessed through blind evaluation of pre and post treatment (12-week) photographs; percentage change in the adipose tissue thickness from baseline to the 12-week follow up measured through ultrasound imaging; and patient satisfaction measured at the 12-week post treatment follow up visit.
Interested in learning more about SculpSure?
Please call our office today to schedule your SculpSure consultation.