|
Device | STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM |
Generic Name | excimer laser system |
Applicant |
AMO Manufacturing USA, LLC |
510 cottonwood drive |
milpitas, CA 95035 |
|
PMA Number | P930016 |
Supplement Number | S044 |
Date Received | 11/10/2014 |
Decision Date | 05/06/2015 |
Product Code |
LZS
|
Docket Number | 15M-1707 |
Notice Date | 07/15/2015 |
Advisory Committee |
Ophthalmic |
Supplement Type | panel track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
|
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). |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
|