NIDEK EC-5000 EXCIMER LASER SYSTEM

FDA premarket approval P970053/S009 · decided 2006-10-11

Approval details

PMA number

P970053

Supplement

S009

Supplement type

Panel 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

2005-11-23

Decision date

2006-10-11

Days to decision

322 days

Decision code

APPR

Product code

LZS

Advisory committee

Ophthalmic

Expedited review

No

Location

Gamagori

Statement

APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE AND A 9.0 MM TREATMENT ZONE AND IS INDICATED FOR LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA REFRACTIVE ERRORS FROM +0.5 TO +5.0 D OF SPHERE WITH OR WITHOUT ASTIGMATIC REFRACTIVE ERRORS FROM +0.5 TO +2.0 D AT THE SPECTACLE PLANE WITH MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +5.0 D OR LESS; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIE

510(k) clearances by this applicant