truSculpt Body Contouring System Gets New FDA Clearance
Cutera Announces Expansion of FDA Indications for the truSculpt® Body Contouring System
BRISBANE, Calif., June 13, 2018 (GLOBE NEWSWIRE) — CUTERA, INC., (Nasdaq:CUTR) (“Cutera” or the “Company”) a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced the U.S. Food and Drug Administration (FDA) has granted clearance of an additional indication, for lipolysis or the 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.”
“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.”
About truSculpt 3D and RF Energy
The truSculpt 3D system utilizes a controlled, monopolar radio frequency (RF) technology to deliver targeted, uniform heating of the subcutaneous adipose tissue to achieve what we believe to be 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.
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.
For more information, please visit the truSculpt product page.
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