PMA P930016S031

Device: VISX STAR S4 IR EXCIMER LASER SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S031
Product code: LZS
Decision date: 2008-12-01
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR MODIFICATION OF THE STARPATIENT'S CHAIR. THE DEVICE, AS MODIFIED, WILL HE MARKETED UNDER THE TRADE NAME STAR S4IR EXCIMER LASER SYSTEM AND IS INDICATED FOR WAVE FRONT-GUIDED (WFG) LASER ASSISTED INSITU KERATOMILEUSIS (LAS1K) 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, ANDMINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIRTARGETED 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 OFPREOPERATIVE EXAMINATION; AND4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISIONEXPERIENCE.

Current openFDA PMA Record#

Device: VISX STAR S4 IR EXCIMER LASER SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S031
Product code: LZS
Generic name: Excimer laser system
Decision date: 2008-12-01
Decision code: APPR
Date received: 2008-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MODIFICATION OF THE STARPATIENT'S CHAIR. THE DEVICE, AS MODIFIED, WILL HE MARKETED UNDER THE TRADE NAME STAR S4IR EXCIMER LASER SYSTEM AND IS INDICATED FOR WAVE FRONT-GUIDED (WFG) LASER ASSISTED INSITU KERATOMILEUSIS (LAS1K) 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, ANDMINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIRTARGETED 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 OFPREOPERATIVE EXAMINATION; AND4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISIONEXPERIENCE.