PMA P970043S008

Device: SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S008
Product code: LZS
Decision date: 2000-07-11
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE CORRESPONDING COMPANY NAME CHANGE, DEVICE NAME CHANGE, AND SOME EXTERNAL CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUMMIT AUTONOMOUS LADARVISION 4000 LASER SYSTEM.

Current openFDA PMA Record

Device: SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S008
Product code: LZS
Generic name: Excimer laser system
Decision date: 2000-07-11
Decision code: APPR
Date received: 2000-05-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CORRESPONDING COMPANY NAME CHANGE, DEVICE NAME CHANGE, AND SOME EXTERNAL CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUMMIT AUTONOMOUS LADARVISION 4000 LASER SYSTEM.