STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S016 · decided 2003-05-23
Approval details
- PMA number
- P930016
- Supplement
- S016
- Supplement type
- Panel 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
- 2002-10-01
- Decision date
- 2003-05-23
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE VIXX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.00 MM OPTICAL ZONE, AN 8.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D; 2) PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D
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