PMA P030008S002

Device: ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S002
Product code: LZS
Decision date: 2005-02-15
Classification: Excimer Laser System
Generic name: Excimer laser system
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.

Current openFDA PMA Record#

Device: ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S002
Product code: LZS
Generic name: Excimer laser system
Decision date: 2005-02-15
Decision code: APPR
Date received: 2005-01-31
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.