SculpSure in September 2017 was approved by the FDA for non-invasive contouring of the submental area–usually known as a double chin. This requires an additional hand-piece for the SculpSure device, which was originally approved for non-invasive body contouring. The specialized hand-piece holds the applicator in place in the submental area.
For the SculpSure submental approval, 57 patients received two 25-minute treatments six weeks apart. Six weeks after the second treatment, fat thickness was evaluated with photographs and ultrasound, with patients generally showing an improvement in contour.
The procedure was generally well-tolerated. Swelling and tenderness for a few days was common after treatment. Some patients had firm areas that required several weeks to resolve.