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. |
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Device | LADARVISION 4000 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S014 |
Date Received | 08/21/2003 |
Decision Date | 09/12/2003 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO BE USED WITH THE LADARVISION 4000 EXCIMER LASER SYSTEM WHICH WILL ALLOW TREATMENT PLANNING BY THE PRACTITIONER PRIOR TO THE ACTUAL DATE OF SURGERY. 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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