STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
FDA premarket approval P930016/S025 · decided 2007-07-11
Approval details
- PMA number
- P930016
- Supplement
- S025
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2006-09-29
- Decision date
- 2007-07-11
- Days to decision
- 285 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 VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USED 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) TO ACHIEVE MONOVISION BY THE TARGETED RETENTION OF MYOPIA (-1.25 TO -2.00 D) IN THE NON-DOMINANT EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH
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