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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 CO., LTD.
PMA NumberP970053
Supplement NumberS012
Date Received09/25/2012
Decision Date12/12/2012
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 replacement of the laser diode for the aiming beam, the corresponding modification of the aiming beam optical system, and associated labeling changes.
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