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.
The laser is compatible with the Visualase Thermal Therapy System, which incorporates advanced MRI-thermal image guidance and novel cooled laser applicator technology for real-time monitoring and control of the ablation process. The new PhoTex30 Diode Laser and Visualase cooled laser applicators allow creation of large ablation zones (up to 3cm in diameter) from a single probe in approximately 2 minutes. Multiple probes can be used simultaneously to cover larger areas of tissue in the same short exposure time. .
Visualase uses light energy to destroy unwanted tissue through a process called Laser-induced interstitial thermotherapy (LITT). In this treatment, laser fibers are directed to targeted areas in the body, often tumor tissue. Laser light is delivered through the probe which raises the temperature to lethal levels in the targeted tissue. As more physicians become trained on the Visualase technology, lasers may have an increased impact on many types of tumor therapy. Doctors are currently using the system for ablation of brain, prostate, liver, bone, and other solid tumors.
PhoTex30 Diode Laser System
For more information about the PhoTex30 Diode Laser Series and Visualase Inc., visit http://www.visualaseinc.com.
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Contact
Andres Schulz
Media and Marketing
Visualase Inc.
8058 El Rio Street
Houston, Texas 77054
FDA Statement