PMA P970043S006

Device: LADAR VISION EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S006
Product code: LZS
Decision date: 2000-01-07
Generic name: Excimer laser system
Approval order statement: Addition of the following statement to the warnings section: "A minimum of pre-operative pupillary dilation of 7mm and a maximum dilation of 11mm must be achieved and maintained in all patients throughout the refractive procedure to optimize tracker performance.

Current openFDA PMA Record

Device: LADAR VISION EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S006
Product code: LZS
Generic name: Excimer laser system
Decision date: 2000-01-07
Decision code: APPR
Date received: 1999-09-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Addition of the following statement to the warnings section: "A minimum of pre-operative pupillary dilation of 7mm and a maximum dilation of 11mm must be achieved and maintained in all patients throughout the refractive procedure to optimize tracker performance.