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FDA Approves Laser Module For Paradigm Medical

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SALT LAKE CITY, Utah, June 11 -- Paradigm Medical Industries Inc. said that the US Food and Drug Administration (FDA) has approved a second laser module for the company's Photon Laser System Workstation. The 810 nm red diode will allow the system to perform additional eye surgery procedures. Last October, Paradigm received FDA approval to market the 532 nm green laser module for multiple eye surgery procedures.
    "The ultrasound portion of the Photon Laser System for cataract removal has already been approved by FDA," said Tracy Best, Paradigm Medical's Director of Regulatory Affairs. "By adding laser surgical filtering indications for glaucoma, the surgical range for the Photon Workstation has been expanded to allow access to almost all the surgical subspecialties in eye care."
    Best noted that the 810 nm red diode laser will find application for such indications for glaucoma as transcleral cyclophotocoagulation, transcleral endo-cyclophotocoagulation, ablation of the ciliary process for the reduction of the intra-ocular pressure, and retinal photocoagulation used for diabetic patients.
Jun 2001
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