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Nidek

This article was originally published in The Gray Sheet

Executive Summary

PMA supplement submission for the EC-5000 excimer laser system would add hyperopia and hyperopia with astigmatism indications as part of the LASIK procedure. The EC-5000 currently is approved for myopia with or without astigmatism. Firm also submits 510(k) for the OPD Scan device that generates refractive eye maps of the corneal surface
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