FDA 510(k) Applications Submitted by Yoneji Mizuno

FDA 510(k) Number Submission Date Device Name Applicant
K170302 01/31/2017 YELLOW LASER PHOTOCOAGULATOR YLC-500 NIDEK CO., LTD.
K181345 05/21/2018 Image Filing Software NAVIS-EX Nidek Co., Ltd
K151706 06/24/2015 Specular Microscope CEM- 530 NIDEK CO., LTD.
K131894 06/25/2013 NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT NIDEK CO., LTD.
K152603 09/11/2015 Green Laser Photocoagulator GYC-500 NIDEK CO., LTD.
K152729 09/22/2015 MICROPERIMETER MP-3 NIDEK CO., LTD.
K163564 12/19/2016 SLIT LAMP SL-2000 NIDEK CO., LTD.
K173980 12/29/2017 Specular Microscope CEM-530 Nidek Co., Ltd.


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