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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
34-14 maehama, hiroishi-cho
gamagori, aichi 443-0-0038
PMA NumberP970053
Supplement NumberS011
Date Received03/30/2007
Decision Date09/30/2013
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 13M-1362
Notice Date 10/30/2013
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the nidek ec-5000 excimer laser system. This device is indicated for topography-assisted laser- assisted in-situ keratomileusis (lasik) treatment using the final fit¿ custom ablation treatment planning software for the reduction or elimination of myopic refractive errors from -1. 0 to -4. 0 d of sphere with astigmatic refractive errors from >-0. 5 to -2. 0 d at the spectacle plane; in patients 21 years of age or older; and, in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than ±0. 5 d.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2