- FDA Approves Endoscopic Video System
WORCESTER, Mass., Nov. 10 -- Luxtec Corp. announced that the US Food and Drug Administration has approved the US marketing of the endoscopic video recording system developed by Luxtec's Fiber Imaging Technologies (FIT) subsidiary and its German partner, Schoelly Fiberoptic GmbH. With the FDA Section 510(k) approval, FIT is able to market the visualization system to OEMs for inclusion in subsystems sold to surgeons and physicians to facilitate endoscopic observation and recording of surgical sites. The FIT system includes a video camera and control unit that attaches to an illuminated endoscope through a fiber optic cable to allow viewing and recording of body areas being examined.
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