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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.
 
DeviceLASER SCAN LSX EXCIMER LASER
Generic Nameexcimer laser system
ApplicantLASERSIGHT TECHNOLOGIES, INC.
6903 university blvd.,
winter park, FL 32792
PMA NumberP980008
Supplement NumberS003
Date Received07/20/2000
Decision Date08/15/2000
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE LASER PULSE REPETITION RATE FROM 100 TO 200 HZ.
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