Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: VISX MODELB/MODEL C EXCIMER LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: AMO Manufacturing USA, LLC; 510 Cottonwood Drive; Milpitas, CA 95035
• PMA Number: P910062
• Date Received: 10/16/1991
• Decision Date: 09/29/1995
• Product Code: LZS
• Docket Number: 96M-0486
• Notice Date: 12/23/1996
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR VISX EXCIMER LASER SYSTEM (MODELS B & C)

• Supplements: S001 S004 S006 S007 S008