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Device | LASERSCAN LSX EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | LASERSIGHT TECHNOLOGIES, INC. 6903 UNIVERSITY BLVD., WINTER PARK, FL 32792 |
PMA Number | P980008 |
Supplement Number | S009 |
Date Received | 10/26/2001 |
Decision Date | 11/09/2001 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE. |