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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
34-14 maehama, hiroishi-cho
gamagori, aichi 443-0-0038
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling