FDA approves first surgical treatment to remove cellulite
The FDA has approved Cellulaze, a single-treatment laser that affects the physiological structure of cellulite. Cellulaze, which previously gained approval in the U.K., was developed by Cynosure, a global aesthetic laser manufacturer and creator of the SmartLipo laser.
"Cellulaze is the world's first surgical treatment for cellulite designed to treat women who have struggled to eliminate cellulite through diet and exercise," said Cynosure president and CEO Michael Davin.
Unlike temporary, non-invasive treatments on the market, Cellulaze is the only aesthetic device that directly treats the physiological structure of cellulite, with clinically proven results. In the U.S. alone, patient trials have demonstrated that after two years post-procedure no cellulite has returned to the areas treated.
Four years of clinical data has demonstrated that Cellulaze treatments can increase the thickness of the skin by 25% and increase the elasticity of the skin by 29% at one year.
"We have been extremely fortunate that in Europe the Cellulaze laser treatment has CE mark approval prior to the awaiting FDA approval,” said Neil Wolfenden, Cynosure U.K. managing director. “To-date we have witnessed high patient satisfaction across the board, and impressive national press coverage.”