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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
Classification Nameexcimer laser system
ApplicantNIDEK, INC.
PMA NumberP970053
Supplement NumberS010
Date Received08/10/2006
Decision Date11/08/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the nidek ec-5000 excimer laser system (model cxii) including a reduction in size, the standardization of previously optional features, incorporating the control computer into the computer (previously stand-alone) and replacing the original (manual magnification) microscope with a new model with motorized magnification control. The new device will be named the nidek ec-5000 excimer laser system model cxiii.
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