-Fremont CA, USA, October 20, 2000-
NIDEK, Inc. announced today it has submitted a 510(k) application for the OPD Scan to the U.S. Food and Drug Administration. Once this application is accepted for filing, the FDA will evaluate the NIDEK OPD Scan as a stand-alone device that generates refractive eye maps. The OPD Scan is currently in U.S. beta-site testing.
NIDEK's new OPD Scan is a state-of-the-art diagnostic instrument that combines auto-refraction, corneal topography and wavefront analysis to create unique refractive power maps of the corneal surface. These maps are much more precise than traditional autorefractometers and represent a powerful diagnostic tool. Current stand-alone devices only use wavefront analysis to create a map of the eye's refractive errors.
"This technology will change the way that laser vision correction procedures are performed," said Hiroshi Okada, vice president and general manager, NIDEK Inc. "Refractive surgeons can create topographical maps to help them provide the best optical outcome in laser vision correction procedures. NIDEK is proud to be involved in developing and providing new methods for the vision care industry and patients."
NIDEK's research and development division, NIDEK Technologies, is developing a compatible system that will enable the OPD Scan to interface with the EC-5000 Excimer Laser System and their proprietary equipment to produce custom ablations in laser vision correction.
For more information, please contact Hiroshi Okada, General Manager, Regulatory, QA & Legal Affairs of NIDEK Inc., Fremont CA, at (510) 226-5700 or by fax at (510) 226-5750.
