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