PMA P030008S019

Device: WAVELIGHT EX500 LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S019
Product code: LZS
Decision date: 2015-06-02
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).

Current openFDA PMA Record#

Device: WAVELIGHT EX500 LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S019
Product code: LZS
Generic name: Excimer laser system
Decision date: 2015-06-02
Decision code: APPR
Date received: 2015-02-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).