STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS
FDA premarket approval P930016/S019 · decided 2005-02-18
Approval details
- PMA number
- P930016
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2004-09-07
- Decision date
- 2005-02-18
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN IRIS IDENTIFICATION AND REGISTRATION SYSTEM AND AN OZONE SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAR S4-IR EXCIMER LASER SYSTEM.
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