PMA P930016S044
- Device
- STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S044
- Product code
- LZS
- Decision date
- 2015-05-06
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM. THIS DEVICE USES A 6.0 MM OPTICAL ZONE, AND 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS:1) WITH MYOPIA AS MEASURED BY THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM UP TO -11 D SPHERICAL EQUIVALENT WITH UP TO -5 D CYLINDER; AND2) WITH AGREEMENT BETWEEN MANIFEST REFRACTION (ADJUSTED FOR OPTICAL INFINITY) AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM REFRACTION AS FOLLOWS:1) SPHERICAL EQUIVALENT: MAGNITUDE OF THE DIFFERENCE IS LESS THAN 0.625 D; AND 2) CYLINDER: MAGNITUDE OF THE DIFFERENCE IS LESS THAN OR EQUAL TO 0.5 D; A) 18 YEARS OF AGE OR OLDER; AND B) WITH REFRACTIVE STABILITY (A CHANGE OF ¿ 1.0 D IN SPHERE OR CYLINDER FOR A MINIMUM OF 12 MONTHS PRIOR TO SURGERY).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016S044B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S044
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2015-05-06
- Decision code
- APPR
- Date received
- 2014-11-10
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM. THIS DEVICE USES A 6.0 MM OPTICAL ZONE, AND 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS:1) WITH MYOPIA AS MEASURED BY THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM UP TO -11 D SPHERICAL EQUIVALENT WITH UP TO -5 D CYLINDER; AND2) WITH AGREEMENT BETWEEN MANIFEST REFRACTION (ADJUSTED FOR OPTICAL INFINITY) AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM REFRACTION AS FOLLOWS:1) SPHERICAL EQUIVALENT: MAGNITUDE OF THE DIFFERENCE IS LESS THAN 0.625 D; AND 2) CYLINDER: MAGNITUDE OF THE DIFFERENCE IS LESS THAN OR EQUAL TO 0.5 D; A) 18 YEARS OF AGE OR OLDER; AND B) WITH REFRACTIVE STABILITY (A CHANGE OF ¿ 1.0 D IN SPHERE OR CYLINDER FOR A MINIMUM OF 12 MONTHS PRIOR TO SURGERY).