-Fremont, CA, USA, November 6, 2001-
NIDEK, Inc. announced today that it has received supplemental pre-market approval from the U.S. Food and Drug Administration for the NIDEK EC-5000 Excimer Laser System to utilize an increased optical zone during the LASIK procedure. The NIDEK EC-5000 is now FDA-approved for a 6.5 mm optical zone in the treatment of myopia and myopia with astigmatism, as part of LASIK. This expanded optical zone may be used with a 7.5 mm transition zone in treating myopia and myopia with astigmatism using LASIK.
"Increasing the size of the optical zone approval opens the door for expanded treatment parameters and options on the EC-5000," commented Hiroshi Okada, vice president and general manager, NIDEK, Inc. "It is our continued endeavor to provide refractive surgeons with state-of-the-art tools to treat a broad range of refractive errors using our innovative, technologically advanced platform."
The increased optical zone will allow refractive surgeons greater ability to treat larger areas on the cornea during the LASIK procedure. This may also prove to be beneficial to patients who have pupils larger than normal, and were previously not candidates for LASIK.
