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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic NameExcimer laser system
ApplicantNIDEK CO., LTD.
GAMAGORI, AICHI 443-0-0038
PMA NumberP970053
Date Received11/06/1997
Decision Date12/17/1998
Product Code LZS 
Docket Number 00M-1640
Notice Date 12/08/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017