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 | LADAR 6000 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S019 |
Date Received | 11/30/2004 |
Decision Date | 05/01/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES IN THE LADARVISION 4000 SYSTEM INCLUDING A NEW CONFIGURATION OF THE ILLUMINATION SYSTEM, UPGRADES TO THE LASER COMPUTER AND OPERATING SYSTEM, AND VARIOUS OTHER HARDWARE AND SOFTWARE CHANGES INTENDED TO ADDRESS COMPLIANCE WITH EMI REQUIREMENTS, MANAGE COMPONENT OBSOLESCENCE, REDUCE MAINTENANCE REQUIREMENTS, AND ENHANCE ERGONOMIC AND USER INTERFACE FEATURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADAR 6000 EXCIMER LASER SYSTEM. |
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