Nidek Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX, Ophthalmic Yag Laser System YC-200, Ophthalmic Yag Laser System YC-200
20
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nidek Co., Ltd. Ophthalmic ✕
19 devices
Cleared
CT
Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
Ophthalmic
328d
Cleared
Dec 07, 2020
Ophthalmic Yag Laser System YC-200
Ophthalmic
49d
Cleared
Nov 15, 2019
Ophthalmic Yag Laser System YC-200
Ophthalmic
107d
Cleared
Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
Ophthalmic
56d
Cleared
Jul 19, 2018
Image Filing Software NAVIS-EX
Ophthalmic
59d
Cleared
CT
Mar 14, 2018
Specular Microscope CEM-530
Ophthalmic
75d
Cleared
Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
Ophthalmic
143d
Cleared
May 19, 2017
SLIT LAMP SL-2000
Ophthalmic
151d
Cleared
Jun 06, 2016
MICROPERIMETER MP-3
Ophthalmic
258d
Cleared
May 02, 2016
Green Laser Photocoagulator GYC-500
Ophthalmic
234d
Cleared
Mar 17, 2016
Specular Microscope CEM- 530
Ophthalmic
267d
Cleared
Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
Ophthalmic
285d