Nidek receives CE Mark for excimer laser system

Lisbon, Portugal - Nidek Co., Gamagori, Japan, has received a CE Mark for its new and advanced refractive surgery laser system, the 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, the company said.

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 European market, assuring physicians and patients of the safety of the product.

The new excimer laser platform, part of the Nidek NAVEX Quest System brings together advanced hardware modules - including 200 Hz eye tracking, torsion error detection and compensation, and multipoint laser delivery - along with innovative and proprietary software algorithms such as Nidek’s OATz, CATz, and OPDCAT for customized refractive surgery. The new laser system will work alongside Nidek’s advanced diagnostic platform, the OPD-Scan, and Final-Fit Software for performing customized and personalized refractive surgery procedures. 

“This approval brings a major milestone for Nidek, as we continue to deliver and commercialize new and innovative refractive surgery solutions to users around the world, especially in Europe and the Middle East,” said Motoki Ozawa, vice president of Nidek. “The new EC-5000CXIII excimer laser system brings together more than 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.”

For more information, visit Nidek at Booth #227.