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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
Classification Nameexcimer laser system
ApplicantNIDEK, INC.
PMA NumberP970053
Supplement NumberS008
Date Received04/22/2004
Decision Date05/28/2004
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to replace the 60hz eyetracker with the 200 hz eyetracker in the nidek ec-5000 excimer laser system for the treatment of myopia and myopic astigmatism.
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