Houston, Texas October 6, 2009. The U.S. FDA granted 510(k) clearance (K092197) for the PhoTex30 Diode Laser Series, Model 980nm, 810nm, 940nm. The PhoTex30 Diode Laser Series, distributed by Visualase, Inc. received broad clearance for use in surgical applications requiring ablation and coagulation of soft tissue including general surgery, urology, neurosurgery, and other surgical specialties.
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Visualase will be holding a seminar for physicians interested in the Visualase technology. Neurosurgeons that have used Visualase will present case studies and will be available for QnA. Please RSVP if you like to attend. There is limited capacity for this event.
“World first: Lasers used in keyhole surgery for brain cancer” – Agence France-Presse
Paris, France August 29th, 2008 – Visualase technology used to successfully treat brain tumors, as reported by AFP and the Telegraph (UK).
Read: AFP article | Telegraph article
Paris hospital hosts pioneering laser brain surgery
Saturday 30 August 2008 – A French team of neurosurgeons claims top have successfully tested a combination of new techniques, including fibre-optic lasers, in treating brain cancer through ultra-keyhole surgery.
Read: France24
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.
Shabbar F. Danish, M.D., Director, Stereotactic and Functional Neurosurgery and Assistant Professor at UMDNJ-Robert Wood Johnson Medical School (RWJMS) and Robert Wood Johnson University Hospital (RWJUH), used the Visualase, Inc., laser-assisted thermal ablation technique to operate on a patient with a recurring brain tumor after two previous surgeries and radiation did not permanently destroy the growth.
FDA Statement