PMA P970043S003

Device: LADAR VISION EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S003
Product code: LZS
Decision date: 1999-05-12
Generic name: Excimer laser system
Approval order statement: Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual. The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during treatment).

Current openFDA PMA Record

Device: LADAR VISION EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S003
Product code: LZS
Generic name: Excimer laser system
Decision date: 1999-05-12
Decision code: APPR
Date received: 1999-04-16
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual. The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during treatment).