| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | VISX STAR S4 IR EXCIMER LASER SYSTEM |
|---|
| Generic Name | Excimer laser system |
|---|
| Applicant | AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 |
|---|
| PMA Number | P930016 |
|---|
| Supplement Number | S031 |
|---|
| Date Received | 08/11/2008 |
|---|
| Decision Date | 12/01/2008 |
|---|
| Product Code |
LZS |
| Advisory Committee |
Ophthalmic |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
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. |
|
|
