NIDEK EC-5000 EXCIMER LASER SYSTEM

FDA premarket approval P970053/S006 · decided 2001-09-04

Approval details

PMA number

P970053

Supplement

S006

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

NIDEK EC-5000 EXCIMER LASER SYSTEM

Generic name

Excimer laser system

Applicant

Nidek Co., Ltd.

Date received

2001-03-15

Decision date

2001-09-04

Days to decision

173 days

Decision code

APPR

Product code

LZS

Advisory committee

Ophthalmic

Expedited review

No

Location

Gamagori

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

510(k) clearances by this applicant