Nidek Files PMA Supplement for Increased Optical Zone

Apr 26, 2001, 01:00 ET from Nidek, Inc.

    FREMONT, Calif., April 26 /PRNewswire/ -- 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.
     With U.S. operations headquartered in Fremont, California, Nidek, Inc.
 sells and distributes laser systems and diagnostic equipment developed and
 manufactured by Nidek Japan, for uses in ophthalmology, optometry, general
 surgery, gynecology and cosmetic dermatological surgery.  The Company's
 ophthalmic and optometric products are specifically designed for diagnosing
 and treating retinal diseases, glaucoma, refractive therapies, premature
 retinopathy, and pre- and post-operative cataract surgery therapy.  Nidek's
 surgical products are designed to treat patients in the growing applications
 of cosmetic laser surgery and laser skin resurfacing.  Nidek distributes its
 products through a network of distribution partners and a direct sales force.
 For additional information, please visit the company's website at
 http://www.nidek.com.
 
     For more information, please contact Sam Larson of Nidek, Inc.
 800-223-9044, ext. 707, fax, 510-226-5750; or media, Dawn Verhulst,
 323-848-4300, dawnv@carryonpr.com, for Nidek, Inc.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X62238128
 
 

SOURCE Nidek, Inc.
    FREMONT, Calif., April 26 /PRNewswire/ -- 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.
     With U.S. operations headquartered in Fremont, California, Nidek, Inc.
 sells and distributes laser systems and diagnostic equipment developed and
 manufactured by Nidek Japan, for uses in ophthalmology, optometry, general
 surgery, gynecology and cosmetic dermatological surgery.  The Company's
 ophthalmic and optometric products are specifically designed for diagnosing
 and treating retinal diseases, glaucoma, refractive therapies, premature
 retinopathy, and pre- and post-operative cataract surgery therapy.  Nidek's
 surgical products are designed to treat patients in the growing applications
 of cosmetic laser surgery and laser skin resurfacing.  Nidek distributes its
 products through a network of distribution partners and a direct sales force.
 For additional information, please visit the company's website at
 http://www.nidek.com.
 
     For more information, please contact Sam Larson of Nidek, Inc.
 800-223-9044, ext. 707, fax, 510-226-5750; or media, Dawn Verhulst,
 323-848-4300, dawnv@carryonpr.com, for Nidek, Inc.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X62238128
 
 SOURCE  Nidek, Inc.