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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 NameALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantWAVELIGHT LASER TECHNOLOGIE AG
PMA NumberP020050
Supplement NumberS002
Date Received01/31/2005
Decision Date02/15/2005
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for notebook software changes to the new software version (nb-042201) that involve: 1) a change in the notation used to enter refraction; and 2) the software menu location at which users may select different values for flap thickness based on the type of microkeratome used to create corneal flaps.
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