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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 NumberS009
Date Received11/23/2005
Decision Date10/11/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0460
Notice Date 11/14/2006
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. 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 patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than +/- 0. 50 diopter.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling