STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
FDA premarket approval P930016/S020 · decided 2005-03-17
Approval details
- PMA number
- P930016
- Supplement
- S020
- 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)
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2004-09-21
- Decision date
- 2005-03-17
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
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