PMA P970043S007

Device: LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S007
Product code: LZS
Decision date: 2000-09-22
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS WHO ARE 21 YEARS OF AGE OR OLDER.

Current openFDA PMA Record

Device: LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S007
Product code: LZS
Generic name: Excimer laser system
Decision date: 2000-09-22
Decision code: APPR
Date received: 1999-09-03
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS WHO ARE 21 YEARS OF AGE OR OLDER.