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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.
 
DeviceLASERSCAN LSX EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
LASERSIGHT TECHNOLOGIES, INC.
6903 university blvd.,
winter park, FL 32792
PMA NumberP980008
Supplement NumberS009
Date Received10/26/2001
Decision Date11/09/2001
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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