PMA P970053S006

Device: NIDEK EC-5000 EXCIMER LASER SYSTEM
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S006
Product code: LZS
Decision date: 2001-09-04
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL TO MODIFY THE APPROVED CLAIM FOR THE EC-5000 EXCIMER LASER SYSTEM TO ALLOW FOR THREATMENTS USING AN OPTICAL ZONE SIZE OF 5.5 MM TO 6.5 MM, IN ADDITION TO THE APPROVED OPTICAL ZONE SIZE OF T.T MM, FOR LASIK TREATMENT OF MYOPIA AND MYOPIA WITH ASTIGMATISM. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME NIDEK EC-5000 EXCIMER LASER SYSTEM AND REMAINS INDICATED FOR THE REDUCTION OR ELIMINATION OF -1.00 D TO -14.00 D MYOPIA SPHERICAL EQUIVALENT WITH OR WITHOUT <=-4 D ASTIGMATISM.

Current openFDA PMA Record#

Device: NIDEK EC-5000 EXCIMER LASER SYSTEM
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S006
Product code: LZS
Generic name: Excimer laser system
Decision date: 2001-09-04
Decision code: APPR
Date received: 2001-03-15
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE APPROVED CLAIM FOR THE EC-5000 EXCIMER LASER SYSTEM TO ALLOW FOR THREATMENTS USING AN OPTICAL ZONE SIZE OF 5.5 MM TO 6.5 MM, IN ADDITION TO THE APPROVED OPTICAL ZONE SIZE OF T.T MM, FOR LASIK TREATMENT OF MYOPIA AND MYOPIA WITH ASTIGMATISM. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME NIDEK EC-5000 EXCIMER LASER SYSTEM AND REMAINS INDICATED FOR THE REDUCTION OR ELIMINATION OF -1.00 D TO -14.00 D MYOPIA SPHERICAL EQUIVALENT WITH OR WITHOUT