Our specialists at PSS are pleased to announce that the FDA, the U.S. Food and Drug Administration has given SculpSure 510K clearance to treat unwanted areas of fat in a patient’s inner and outer thighs and back. Sculpture has already been cleared by the FDA to treat the flanks and the abdomen. With this new approval, our doctors can now treat five different areas of the body.
SculpSure uses heat between 108 and 117 degrees Fahrenheit to destroy excess fat cells just below a patient’s skin. Though these temperatures remove fat cells, they leave other types of cells unharmed. The damaged fat cells are then absorbed by the body over several weeks.
Researchers conducted prospective and controlled studies at three study centers to evaluate SculpSure’s safety and effectiveness. One hundred and sixty eight subjects participated in the study for a total of 214 treatment areas.
SculpSure’s effectiveness was assessed via blind evaluation of photographs taken before the treatment and 12 weeks after the treatments. Ultrasound imagining measured changes in the thickness of the patient’s adipose, or fat tissue from the baseline to the 12 weeks following the treatment. Researchers also measured patient satisfaction 12 weeks after the treatment during follow-up visits.
Our PSS cosmetic surgeons now have FDA approval to use SculpSure to reduce unwanted fat from our client’s thighs and back as well as their abdomens and flanks. Patients in the Annapolis area are urged to set up consultations to see what PSS’s new SculpSure protocol can do for them.