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: STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
• Generic Name: Excimer laser system
• Applicant: Amo Manufacturing USA, LLC; 510 Cottonwood Dr.; Milpitas, CA 95035
• PMA Number: P930016
• Supplement Number: S020
• Date Received: 09/21/2004
• Decision Date: 03/17/2005
• Product Code: LZS
• Docket Number: 05M-0151
• Notice Date: 04/19/2005
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.

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