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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.
 
DeviceLASERSCAN LSX EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantLasersight Technologies, Inc.
6903 University Blvd.,
Winter Park, FL 32792
PMA NumberP980008
Supplement NumberS009
Date Received10/26/2001
Decision Date11/09/2001
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.
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