PMA P030008S030

Device: WaveLight EX500 Laser System/Allegro Topolyzer Vario
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S030
Product code: LZS
Decision date: 2019-12-13
Generic name: Excimer laser system
Approval order statement: Approval for changes to the software for the Allegro Topolyzer VARIO Diagnostic System related to the graphic user interface (GUI), workflow processing and improvements of picture recognition by increasing resolution.

Current openFDA PMA Record#

Device: WaveLight EX500 Laser System/Allegro Topolyzer Vario
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S030
Product code: LZS
Generic name: Excimer laser system
Decision date: 2019-12-13
Decision code: APPR
Date received: 2019-09-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the software for the Allegro Topolyzer VARIO Diagnostic System related to the graphic user interface (GUI), workflow processing and improvements of picture recognition by increasing resolution.