PMA P930016S025
- Device
- STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S025
- Product code
- LZS
- Decision date
- 2007-07-11
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016S025B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S025
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2007-07-11
- Decision code
- APPR
- Date received
- 2006-09-29
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.