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) AND WAVESCAN WAVEFRONT SYSTEM
• Generic Name: Excimer laser system
• Applicant: AMO Manufacturing USA, LLC; 510 Cottonwood Drive; Milpitas, CA 95035
• PMA Number: P930016
• Supplement Number: S021
• Date Received: 03/08/2005
• Decision Date: 08/30/2005
• Product Code: LZS
• Docket Number: 05M-0382
• Notice Date: 09/23/2005
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA AND MYOPIC ASTIGMATISM FROM -6.0 TO -11.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER, AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.00 D (IN BOTH 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