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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEXCIMED(TM) UV200LA LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
6201 south freeway
fort worth, TX 76134
PMA NumberP910067
Date Received11/20/1991
Decision Date03/10/1995
Withdrawal Date 05/18/2010
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 95M-0179
Notice Date 07/06/1995
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 
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