NIDEK Receives CE Mark Approval for NIDEK EC-5000CXIII Excimer Laser System
-September 12, 2005 - Gamagori, JAPAN -
NIDEK Co. Ltd. announced that it has received CE Mark approval for its new and advanced refractive surgery laser system the - NIDEK EC-5000CXIII. This regulatory milestone clears the way for NIDEK to commercialize and market the new laser platform for refractive surgery, throughout the world, especially in Europe and the Middle East.
“This approval brings a major milestone for NIDEK, as we continue to delivery and commercialize new and innovative refractive surgery solutions to users around the world, especially in Europe and the Middle East. The new EC-5000CXIII excimer laser system brings together over 10+ years of research and development and we are extremely proud and confident of the laser platform and the clinical outcomes users will get around the world,” said Motoki Ozawa, Vice President of NIDEK Co. Ltd. “The new refractive surgery platform, part of NIDEK’s NAVEX Quest System brings together advanced hardware modules and innovative software algorithms into one compact, robust and technologically advanced refractive surgery excimer laser system. We remain confident that users and treated patients around the world will greatly benefit from using this new platform,” added Mr. Motoki Ozawa.
The new excimer laser platform, part of the NIDEK NAVEX Quest System brings together advanced hardware modules, like 200 Hz eye tracking, torsion error detection and compensation, multi-point laser delivery, along with innovative and proprietary software algorithms like NIDEK’s OATz, CATz and OPDCAT for customized refractive surgery. The new laser system will work along-side NIDEK’s advanced diagnostic platform the NIDEK OPD-Scan and NIDEK’s Final-Fit Software for performing customized and personalized refractive surgery procedures. NIDEK also offers a microkeratome system - the NIDEK MK-2000 Keratome System as part of the overall NAVEX Quest Platform. The NAVEX Quest Platform provides a complete treatment platform for primary, highly aberrated eyes and Post-LASIK eyes with suboptimal outcomes. Future add-ons for the new platform will be software algorithms for treating presbyopia with the excimer laser - an area of great research and development at NIDEK.
“The NIDEK EC-5000CXIII Excimer Laser System delivers a compact, highly efficient, robust and reliable excimer surgery platform for users around the world. With close to 1,100 units installed world wide, NIDEK users have been asking for a new platform that beings together the advancements and extensive research that NIDEK has undertaken for the last 10+ years. The new EC-5000CXIII continues to be an upgradeable platform as technology continues to advance and new advancements are made, NIDEK will be able to introduce modules that would be easily added to the new EC-5000CXIII platform - these could include both hardware and software upgrades. New and advanced softwares will include presbyopia treatment solutions that will be add-ons to the existing laser platform. Extensive field-testing has been done with the new platform and the patient outcomes have been stellar and outstanding and the reliability of the new units have been excellent. We continue our long-standing commitment to delivering outstanding solutions for refractive surgery around the world and we look forward to making the new EC-5000CXIII Laser System a great success in Europe, Middle East and Asia,” noted Mr. Motoki Ozawa
The CE Mark is an indication that a company has met essential health, safety and environmental protection requirements detailed in 22 European Directives covering an array of products including medical devices. The CE Mark allows products to gain access to the EU market, assuring physicians and patients of the safety of the product.
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Public Relations, Planning Dept.