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Lumenis Receives 510K Clearance for the PolyScope Disposable Flexible Endoscope
Date:10/27/2009

SANTA CLARA, Calif., Oct. 27 /PRNewswire/ -- Lumenis Ltd., a global developer, manufacturer and seller of laser, light-based and radiofrequency devices for surgical, aesthetic, and ophthalmic applications, announced that on September 30th, 2009 the FDA issued a 510K to Lumenis stating that the PolyScope Flexible Endoscope can now be sold in the United States.

Under this 510K, the PolyScope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

  • Urology, including procedures involving the bladder, ureter, renal pelvis and kidney
  • Gastroenterology, including procedures of the Biliary system involving the hepatic and pancreatic ducts

The PolyScope is an evolution in flexible scope design incorporating a truly disposable endoscopic catheter system with a reusable 10,000 pixel fiber optic. This unique concept solves many of the drawbacks encountered with the use of reusable flexible scopes such as costly and frequent repairs. In addition to the expense, broken scopes create inefficiencies in case load management and staff time needed to complete the logistics of repair and replacement. Scope reprocessing and the potential for contamination is also an issue that is substantially improved with the disposable PolyScope system.

"The clearance of the PolyScope is a significant strategic milestone for the Lumenis Surgical Division," said Dov Ofer, Lumenis' President and CEO. "A strategic focus in the growth of our surgical business has been to build on our core competency in surgical laser systems by adding disposable product lines that complement our current medical applications. This initial clearance for the PolyScope further advances our leadership position in Urology where stones, tumors and strictures are treated through flexible endoscopes using our VersaPulse® holmium lasers and SlimLine(TM) fib
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SOURCE Lumenis Ltd.
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