NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

FDA premarket approval P970053/S001 · decided 1999-09-29

Approval details

PMA number

P970053

Supplement

S001

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

Generic name

Excimer laser system

Applicant

Nidek Co., Ltd.

Date received

1999-02-16

Decision date

1999-09-29

Days to decision

225 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 for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the

510(k) clearances by this applicant