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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 NameMEL 80 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system(193 nanometer wavelenght)
ApplicantCARL ZEISS, INC.
PMA NumberP060004
Supplement NumberS002
Date Received01/18/2008
Decision Date02/14/2008
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change regarding an alternate laser source.
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