FDA grants clearance for the Visualase System
Houston, Texas March 1st, 2006 The U.S. FDA granted 510(k) clearance (K053087) for the Visualase Cooled Laser Applicator System. The Visualase Cooled Laser Applicator System, manufactured by BioTex, Inc. and to be distributed by Visualase, Inc. received clearance for marketing with broad use in a number of medical specialties. “This family of products consists of a number of novel advancements in laser applicator systems,” stated Dr. Ashok Gowda, President and CEO of Visualase. “The laser diffusing fiber and cooling catheter system can be used together to allow use of higher laser powers and faster ablation times, while minimizing risk of applicator damage and tissue carbonization,” he added.
FDA Statement