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: LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
• Generic Name: Excimer laser system
• Applicant: Alcon Laboratories; 6201 S. Freeway; Fort Worth,, TX 76134
• PMA Number: P970043
• Supplement Number: S007
• Date Received: 09/03/1999
• Decision Date: 09/22/2000
• Withdrawal Date: 05/15/2012
• Product Code: LZS
• Docket Number: 00M-1612
• Notice Date: 11/21/2000
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS WHO ARE 21 YEARS OF AGE OR OLDER.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling