STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S017 · decided 2004-12-14
Approval details
- PMA number
- P930016
- Supplement
- S017
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2003-11-28
- Decision date
- 2004-12-14
- Days to decision
- 382 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.00 MM OPTICAL ZONE, A 9.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AN D HYPEROPIC ASTIGMATISM UP TO 3.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND 2.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANI
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