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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.
 
Trade NameLASER SCAN LSX EXCIMER LASER
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantLASERSIGHT TECHNOLOGIES, INC.
PMA NumberP980008
Supplement NumberS003
Date Received07/20/2000
Decision Date08/15/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the laser pulse repetition rate from 100 to 200 hz.
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