PMA P970053S001

Device

NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

Applicant

Nidek Co., Ltd.

PMA number

P970053

Supplement

S001

Product code

LZS

Decision date

1999-09-29

Classification

Excimer Laser System

Generic name

Excimer laser system

Approval order statement

Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of <0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of <0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P970053S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>