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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 NumberS008
Date Received10/05/2001
Decision Date10/25/2001
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 to increase the pulse rate of the laser from 100 to 200 hz.
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