Nidek Receives FDA Clearance for the OPD-Scan(TM)

New Device Combines Dynamic Skiascopy With Corneal

Topography to Offer 'Wavefront Plus(TM)'



Apr 03, 2001, 01:00 ET from Nidek, Inc.

    FREMONT, Calif., April 3 /PRNewswire/ -- Nidek, Inc. announced today that
 the Food and Drug Administration has granted 510(k) clearance for the OPD-Scan
 diagnostic system.  Nidek's new OPD (Optical Path Difference) Scan is a
 state-of-the-art diagnostic instrument that combines Dynamic Skiascopy
 technology and Placido disk corneal topography to create unique refractive
 power maps that show the total optical system aberrations within the
 individual eyes of each patient.  Nidek can now market and sell the OPD-Scan
 as a stand-alone device that generates refractive eye maps.
     Nidek's OPD-Scan produces diagnostic image maps to provide high resolution
 (1,440 measurement points for total aberration and autorefractor measurements,
 and 6,480 points or more for corneal topography measurements), a wide
 measurement range (-20 to +22 diopters, with up to 12 diopters of cylinder),
 and a common axis of measurement for optical aberrations and corneal
 topography.  The OPD-Scan also incorporates autorefraction, allowing
 simultaneous data acquisition for all measurements in both timeline and axis.
     "The technology in the OPD-Scan is a step beyond wavefront devices
 utilizing the Hartmann-Shack measurement method," said Hiroshi Okada, General
 Manager and Vice President of Nidek Inc.  "This is why we have coined the term
 'Wavefront Plus.'  With one machine, eye care clinicians can create
 comprehensive, refractive power maps that normally require at least two tests
 on two different machines.  This technology will help them identify the
 optimum outcome for their patients."
     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.
 
     Company Contact: For more information, please contact Sam Larson of Nidek,
 Inc. by phone (800) 223-9044 ext. 707.
 
     Media Contact: Dawn Verhulst for Nidek, Inc., 310-385-8530,
 dawnv@carryonpr.com.
 
 

SOURCE Nidek, Inc.
    FREMONT, Calif., April 3 /PRNewswire/ -- Nidek, Inc. announced today that
 the Food and Drug Administration has granted 510(k) clearance for the OPD-Scan
 diagnostic system.  Nidek's new OPD (Optical Path Difference) Scan is a
 state-of-the-art diagnostic instrument that combines Dynamic Skiascopy
 technology and Placido disk corneal topography to create unique refractive
 power maps that show the total optical system aberrations within the
 individual eyes of each patient.  Nidek can now market and sell the OPD-Scan
 as a stand-alone device that generates refractive eye maps.
     Nidek's OPD-Scan produces diagnostic image maps to provide high resolution
 (1,440 measurement points for total aberration and autorefractor measurements,
 and 6,480 points or more for corneal topography measurements), a wide
 measurement range (-20 to +22 diopters, with up to 12 diopters of cylinder),
 and a common axis of measurement for optical aberrations and corneal
 topography.  The OPD-Scan also incorporates autorefraction, allowing
 simultaneous data acquisition for all measurements in both timeline and axis.
     "The technology in the OPD-Scan is a step beyond wavefront devices
 utilizing the Hartmann-Shack measurement method," said Hiroshi Okada, General
 Manager and Vice President of Nidek Inc.  "This is why we have coined the term
 'Wavefront Plus.'  With one machine, eye care clinicians can create
 comprehensive, refractive power maps that normally require at least two tests
 on two different machines.  This technology will help them identify the
 optimum outcome for their patients."
     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.
 
     Company Contact: For more information, please contact Sam Larson of Nidek,
 Inc. by phone (800) 223-9044 ext. 707.
 
     Media Contact: Dawn Verhulst for Nidek, Inc., 310-385-8530,
 dawnv@carryonpr.com.
 
 SOURCE  Nidek, Inc.