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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 SYSTEMS
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantWAVELIGHT LASER TECHNOLOGIE AG
PMA NumberP030008
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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