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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
Classification Nameexcimer laser system
ApplicantNIDEK TECHNOLOGIES, INC.
PMA NumberP970053
Supplement NumberS001
Date Received02/16/1999
Decision Date09/29/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1664
Notice Date 12/13/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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.
Approval Order Approval Order
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