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: VISX STAR EXCIMER LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: AMO Manufacturing USA, LLC; 510 Cottonwood Drive; Milpitas, CA 95035
• PMA Number: P930016
• Supplement Number: S012
• Date Received: 07/14/2000
• Decision Date: 04/27/2001
• Product Code: LZS
• Docket Number: 01M-0305
• Notice Date: 07/23/2001
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS. THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 2) IN PATIENTS 21 YEARS OF AGE OR OLDER IN TREATMENTS FOR THE REDUCTION OF ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +05 AND +5.0 D SPHERE AT THE SPECTACLE PLANE WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +3.0 D, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.

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