PMA P930016S027

Device: STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S027
Product code: LZS
Decision date: 2007-11-09
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE UPGRADE STAR SOFTWARE VERSION 5.21, STAR SOFTWARE VERSION 5.22 AND THE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.671. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATIMILEUSIS (LASIK) TO ACHIEVE 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 PREOPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.

Current openFDA PMA Record#

Device: STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S027
Product code: LZS
Generic name: Excimer laser system
Decision date: 2007-11-09
Decision code: APPR
Date received: 2007-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE UPGRADE STAR SOFTWARE VERSION 5.21, STAR SOFTWARE VERSION 5.22 AND THE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.671. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATIMILEUSIS (LASIK) TO ACHIEVE 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 PREOPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.