STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S021 · decided 2005-08-30
Approval details
- PMA number
- P930016
- Supplement
- S021
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2005-03-08
- Decision date
- 2005-08-30
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA AND MYOPIC ASTIGMATISM FROM -6.0 TO -11.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER, AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTIO
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