PMA P020050S019

Device: ALLEGRO TOPOLYZER VARIO
Applicant: Alcon Laboratories, Inc.
PMA number: P020050
Supplement: S019
Product code: LZS
Decision date: 2015-05-01
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL TO EXPAND THE APPROVAL OF THE TOPOLYZER VARIO TO INCLUDE ITS USE AS A DIAGNOSTIC DEVICE SUPPORTING THE WAVELIGHT EXCIMER LASERS IN PERFORMING T-CAT LASIK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRO TOPOLYZER VARIO AND IS INDICATED FOR THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) OR ALLEGRO TOPOLYZER VARIO (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK):1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE;2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50 D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.

Current openFDA PMA Record#

Device: ALLEGRO TOPOLYZER VARIO
Applicant: Alcon Laboratories, Inc.
PMA number: P020050
Supplement: S019
Product code: LZS
Generic name: Excimer laser system
Decision date: 2015-05-01
Decision code: APPR
Date received: 2015-02-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO EXPAND THE APPROVAL OF THE TOPOLYZER VARIO TO INCLUDE ITS USE AS A DIAGNOSTIC DEVICE SUPPORTING THE WAVELIGHT EXCIMER LASERS IN PERFORMING T-CAT LASIK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRO TOPOLYZER VARIO AND IS INDICATED FOR THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) OR ALLEGRO TOPOLYZER VARIO (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK):1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE;2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50 D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.