VISX STAR S4 IR EXCIMER LASER SYSTEM
FDA premarket approval P930016/S031 · decided 2008-12-01
Approval details
- PMA number
- P930016
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISX STAR S4 IR EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2008-08-11
- Decision date
- 2008-12-01
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- 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
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