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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 NameALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES,INC
PMA NumberP970043
Supplement NumberS021
Date Received09/26/2005
Decision Date10/14/2005
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 a software calibration "lock-out" feature wherby the laser system will be "locked-out" to prevent the initiation of surgery more than 60 minutes after the last system calibration, a "countdown clock" on the computer monitor which will provide the user with feedback on the remaining time before the system will lock-out, and a software bug fix to correct a certain "bug" from occurring under certain conditions if the ruler tool was used with the tracker engaged during surgery.
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