Microscope, Specular

FDA product code NQE · Class II (moderate risk) · 21 CFR 886.1850 · Ophthalmic

Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.

9510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K191558Konan Specular Microscope XVIINQE · Traditional Konan Medical, Inc.03/26/2020SE
K173980Specular Microscope CEM-530NQE · Traditional Nidek Co., Ltd.03/14/2018SE
K171313EM-4000 Specular MicroscopeNQE · Traditional Tomey Corporation01/19/2018SE
K151706Specular Microscope CEM- 530NQE · Traditional Nidek Co., Ltd.03/17/2016SE
K142417SP-1PSpecular MicroscopeNQE · Traditional Topcon Corporation05/29/2015SE
K130565Specular Microscope CEM-530NQE · Traditional Nidek Co., Ltd.11/27/2013SE
K120264Konan Specular Microscope XivNQE · Special Konan Medical, Inc.04/11/2012SE
K062763Noncon Robo Pachy F&ANQE · Special Konan Medical, Inc.02/22/2008SE
K040373Kerato Analyzer (Eka)NQE · Traditional Konan Medical, Inc.03/19/2004SE

Recalls

RecallProductFirmInitiated
Z-0771-2020 Class IIINIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides…The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC… Nidek, Inc.02/25/2019Terminated
Z-2711-2016 Class IISPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK…Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results… Nidek Inc08/08/2016Terminated