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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.
 
DeviceLADAR VISION TREATMENTS
Generic NameExcimer laser system
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP970043
Supplement NumberS004
Date Received08/19/1999
Decision Date09/24/1999
Withdrawal Date05/15/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.
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