EC-5000 EXCIMER LASER SYSTEM
Trade Name
EC-5000 EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Applicant
NIDEK, INC.
PMA Number
P970053
Date Received
11/06/1997
Decision Date
12/17/1998
Product Code
LZS
Docket Number
00M-1640
Date Notice
12/08/2000
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the nidek ec-5000 excimer laser system. This device is indicated for photorefractive keratectomy (prk) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) in prk treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0. 75 diopters (d) to -13. 00d) spherical equivalent (s. E. ) at the spectacle plan, uncomplicated by refractive astigmatism (i. E. , <0. 75d in any meridian). 2) in patients who have a stable history of pretreatment myopia, that is a change of < 0. 50d in sphere or cylinder in the 12 months period preceding treatment for correction of myopia <-7. 0d s. E. , or a change of <1. 00d in sphere or cylinder for correction of myopia >-7. 0d s. E. 3) in patients who are over 21 years of age.
