FDA 510(k) Applications for Medical Device Product Code "NQE"
(Microscope, Specular)

FDA 510(k) Number Applicant Device Name Decision Date
K040373 KONAN MEDICAL, INC. KERATO ANALYZER (EKA) 03/19/2004
K120264 KONAN MEDICAL, INC. KONAN SPECULAR MICROSCOPE XIV 04/11/2012
K191558 Konan Medical, Inc. Konan Specular Microscope XVII 03/26/2020
K062763 KONAN MEDICAL, INC. NONCON ROBO PACHY F&A 02/22/2008
K151706 NIDEK CO., LTD. Specular Microscope CEM- 530 03/17/2016
K130565 NIDEK CO., LTD. SPECULAR MICROSCOPE CEM-530 11/27/2013
K173980 Nidek Co., Ltd. Specular Microscope CEM-530 03/14/2018
K171313 Tomey Corporation EM-4000 Specular Microscope 01/19/2018
K142417 TOPCON CORPORATION SP-1PSpecular Microscope 05/29/2015


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