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Device | STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S025 |
Date Received | 09/29/2006 |
Decision Date | 07/11/2007 |
Product Code |
LZS |
Docket Number | 07M-0288 |
Notice Date | 07/20/2007 |
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 VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USED 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) TO ACHIEVE MONOVISION BY THE TARGETED RETENTION OF MYOPIA (-1.25 TO -2.00 D) IN THE NON-DOMINANT EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION; 2) WITH MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER UP TO -3.00 D, AND MINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIR TARGETED MYOPIA; 3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PRE-OPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |