Premarket Approval (PMA)

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.

• 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: S020
• Date Received: 05/27/2005
• Decision Date: 05/01/2006
• Withdrawal Date: 05/15/2012
• Product Code: LZS
• Docket Number: 06M-0323
• Notice Date: 08/17/2006
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM. THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AND HYPEROPIC ASTIGMATISM OF +0.75 D TO LESS THAT +5.00 D OF SPHERE WITH UP TO -3.00 D OF CYLINDER (WHICH HAS A MAGNITUDE LESS THAN OR EQUAL TO THE SPHERE IN MINUS CYLINDER CONVENTION) AND UP TO +5.00 CYCLOPLEGIC SPHERICAL EQUIVALENT AT THE SPECTACLE PLANE; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50 D.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2