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Device | VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S024 |
Date Received | 03/30/2006 |
Decision Date | 05/03/2006 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR WAVESCAN SYSTEM SOFTWARE VERSION 3.70 CONTAINING MINOR DESIGN (USER INTERFACE AND STREAMLINED ACQUISITION AND TREATMENT PLANNING MODE) AND LABELING CHANGES. |