STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
FDA premarket approval P930016/S027 · decided 2007-11-09
Approval details
- PMA number
- P930016
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2007-08-08
- Decision date
- 2007-11-09
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE UPGRADE STAR SOFTWARE VERSION 5.21, STAR SOFTWARE VERSION 5.22 AND THE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.671. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATIMILEUSIS (LASIK) TO ACHIEVE EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENC
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