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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FDA Statement