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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLSX EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantLasersight Technologies, Inc.
6903 University Blvd.,
Winter Park, FL 32792
PMA NumberP980008
Supplement NumberS012
Date Received10/31/2002
Decision Date12/16/2002
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN INCREASE OF THE PULSE REPETITION FREQUENCY FROM THE PRESENT VALUE (200 HZ.) TO 300 HZ.
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