-Fremont CA, USA, April 26, 2001-
NIDEK, Inc. announced today that it has filed a pre-market approval supplement with the U.S. Food and Drug Administration requesting approval for an increased optical zone of 6.5 mm for myopia treatments with the NIDEK EC-5000 Excimer Laser System. Currently, the NIDEK EC-5000 is FDA-approved for a 5.5 mm optical zone with a 7.0 mm transition zone in the treatment, reduction and elimination of myopia and myopia with astigmatism, as part of LASIK.
Hiroshi Okada, general manager and vice president of NIDEK, Inc. commented, "We are continuing to file PMA supplements that, when approved, will allow refractive surgeons using our NIDEK EC-5000 system to treat a broader range of refractive errors using the same state-of-the-art scanning-slit technology. Increasing the size of the optical zone may allow for future expanded treatment parameters and options on our innovative, technologically advanced platform."
The NIDEK EC-5000 Excimer Laser System is currently being evaluated for its ability to safely and effectively treat hyperopia (farsightedness) and hyperopia with astigmatism as part of the LASIK procedure.
Additionally, NIDEK recently announced that the FDA granted 510(k) clearance for the OPD-Scan diagnostic system, one of the components used to perform wavefront analysis prior to performing custom ablation via the EC-5000. In conjunction with the OPD-Scan, NIDEK will be sponsoring clinical trials of its custom ablation technology platform with the NIDEK EC-5000 Excimer Laser System, and subsequently seeking approval from the FDA.
For more information, please contact NIDEK, Inc. by phone (800) 223-9044 or by fax at (510) 226-5750.