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NIDEK EC-5000 Excimer Laser System Receives FDA Approval for LASIK


-Fremont CA, USA, April 18, 2000-

NIDEK, Inc. announced today that the FDA has granted PMA supplemental approval for the Company's EC-5000 Excimer Laser System for the treatment of Laser in-situ Keratomileusis, also known as LASIK. The company can now market and sell its excimer laser for LASIK procedures, for the treatment, reduction and elimination of myopia (nearsightedness) with and without astigmatism (uneven curvature of the cornea).

The new approval allows treatments for the reduction or elimination of myopia (nearsightedness), with or without astigmatism (uneven curvature of the cornea), ranging in severity from -1.00 to -14.00 D, in term of manifest refraction spherical equivalent (MRSE), with refractive astigmatism of less than or equal to -4.00 D cylinder by manifest refraction, in patients who are over 21 years of age.

Hiroshi Okada, Vice President and General Manager of NIDEK, Inc. states, "We are very happy with the new approval and indications of treatment granted by the FDA. With this additional FDA approval for the NIDEK EC-5000, we are continuing our long-standing commitment to providing the refractive surgeon with expanded applications for the laser system. This means that doctors can now provide more treatment therapies for nearsighted patients in their practices. The laser vision correction market is rapidly growing and NIDEK is continuing to offer its state-of-the-art product to the surgeon community. We have a compelling technology and we will continue to deliver it to the surgeon community to better and further the field of ophthalmology."

NIDEK's EC-5000 Excimer Laser System is also approved for the reduction and elimination of myopia in the low, moderate and high ranges from -0.75 to -13.00 diopters (D) and moderate myopia with astigmatism ranging in severity from -1.00 to -8.00 D, with a refractive astigmatism from -0.50 to -4.00 D cylinder by manifest refraction, using PRK (Photorefractive Keratectomy).

"NIDEK is dedicated to providing the highest quality solutions and treatment therapies for quality patient care and surgical outcomes," states Mr. Okada. "The EC-5000 now provides expanded treatment options, parameters and an innovative, technologically advanced platform for Refractive Surgery. The NIDEK EC-5000 platform is designed for surgeons' present use as well as future needs, as the field of Refractive Surgery continues to advance and grow. NIDEK is actively working on developing and launching its' custom ablation and wavefront technology platform with the NIDEK EC-5000 Excimer Laser System. Currently this technology is available internationally and will soon be introduced in the U.S. once clinical studies are done," stated Mr. Okada.

For more information, please contact
Hiroshi Okada.
General Manager
Regulatory, QA & Legal Affairs
NIDEK, Inc.
phone (510) 226-5700 or
fax (510) 226-5750.
Business Wire, 04-18-2000


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