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. Fwy.; Fort Worth, TX 76134
• PMA Number: P970043
• Supplement Number: S010
• Date Received: 03/18/2002
• Decision Date: 10/18/2002
• Withdrawal Date: 05/15/2012
• Product Code: LZS
• Docket Number: 02M-0487
• Notice Date: 11/18/2002
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THIS DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -7.0 DIOPTERS (D) AS MEASURED BY MANIFEST REFRACTION, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 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 OF LESS THAN OR EQUAL TO 0.50 D.

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