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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
ApplicantNIDEK CO., LTD.
PMA NumberP970053
Supplement NumberS015
Date Received10/03/2014
Decision Date03/30/2015
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the a new 1 khz eyetracker, which replaces the original 200 hz eyetracker used with the ec-5000 excimer laser. This change also includes modification to the associated camera and software as well as the infrared red (ir) illumination. 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.