FDA Approves Expanded Indication for Cutera’s truSculpt Body Contouring System

Cutera Inc., a provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, has been granted U.S. Food and Drug Administration (FDA) additional indication for its lipolysis (breakdown of fat) on its premier non-surgical body sculpting system, truSculpt 3D.
 
“TruSculpt’s approval for lipolysis is exciting in two ways,” said Dr. Ashish Bhatia, associate professor of clinical dermatology at Northwestern University’s Feinberg School of Medicine. “First, it confirms how this technology works to reduce areas of unwanted fat, and second, we know that lipolysis of fat cells leads to lasting results, which is great for our patients.”
 
The truSculpt 3D system utilizes a controlled, monopolar radio frequency (RF) technology to deliver targeted, uniform heating of the subcutaneous adipose tissue to achieve the highest clinical efficacy in the shortest possible treatment time. Focusing on three specific characteristics—dimension, definition, and depth—truSculpt 3D offers an optimized and customizable approach to body sculpting for most size areas, large or small.
 
“Today’s announcement is a major milestone for our company and demonstrates our commitment in providing both our physician customers and patients one of the most effective body contouring solutions in the market today with clinically proven efficacy,” said James Reinstein, president and CEO of Cutera Inc. “truSculpt 3D continues to demonstrate excellent market traction and is an important contributor to our planned revenue growth.  We will continue to develop technologies that advance the medical aesthetics industry and meet the needs of our customers and their patients.”
 
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation. Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
 
Brisbane, Calif.-based Cutera provides laser and other energy-based aesthetic systems for practitioners worldwide. Since 1998, Cutera has been developing products that enable physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients.