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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS025
Date Received02/01/2006
Decision Date07/05/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN EXPANSION OF THE ALLOWABLE RANGE FOR THE PHYSICIAN ADJUSTMENT OF DEFOCUS OFFSET PARAMETER FOR THE WAVEFRONT-GUIDED MYOPIA AND MYOPIC ASTIGMATISM INDICATIONS FROM +=0.75 D TO UP TO 1.00 D INCREASE (MORE MYOPIC TREATMENT) AND UP TO 2.50 D DECREASE (LESS MYOPIC TREATMENT).
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