STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S030 · decided 2008-01-16
Approval details
- PMA number
- P930016
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2007-11-21
- Decision date
- 2008-01-16
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE UPGRADE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.90. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WRG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TO ACHIEVE 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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