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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 NameLASERSCAN LSX EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantLASERSIGHT TECHNOLOGIES, INC.
PMA NumberP980008
Supplement NumberS009
Date Received10/26/2001
Decision Date11/09/2001
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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