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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantNIDEK CO., LTD.
PMA NumberP970053
Supplement NumberS002
Date Received04/19/1999
Decision Date04/14/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0014
Notice Date 01/16/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Indications for use of the nidek ec-5000 excimer laser system.
Approval Order Approval Order