STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S018 · decided 2004-06-07
Approval details
- PMA number
- P930016
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2003-12-15
- Decision date
- 2004-06-07
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR SOFTWARE UPGRADE: WAVESCAN SOFTWARE VERSION 3.5 CHANGES FROM CURRENTLY APPROVED VERSION 3.07 (UNDER P930016/S016) FOR VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM FOR WAVEFRONT-GUIDED LASIK TREATMENTS OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D.
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