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Device | ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P020050 |
Supplement Number | S002 |
Date Received | 01/31/2005 |
Decision Date | 02/15/2005 |
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 NOTEBOOK SOFTWARE CHANGES TO THE NEW SOFTWARE VERSION (NB-042201) THAT INVOLVE: 1) A CHANGE IN THE NOTATION USED TO ENTER REFRACTION; AND 2) THE SOFTWARE MENU LOCATION AT WHICH USERS MAY SELECT DIFFERENT VALUES FOR FLAP THICKNESS BASED ON THE TYPE OF MICROKERATOME USED TO CREATE CORNEAL FLAPS. |