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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 NameLADARVISION 4000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES,INC
PMA NumberP970043
Supplement NumberS013
Date Received07/02/2003
Decision Date07/16/2003
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an expansion of +- 0. 75 d for the allowable target offset parameter range for the wavefront-guided myopic lasik indication. The device, as modified, will be marketed under the trade name ladarvision 4000 excimer laser system and is indicated for the reduction or elimination of myopia up to -7. 00 d with less than -0. 50 d of astigmatism at the spectacle plane.
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