Nidek Co., Ltd. - FDA 510(k) Cleared Devices
20
Total
19
Cleared
0
Denied
Nidek Co., Ltd. has 19 FDA 510(k) cleared ophthalmic devices. Based in Lake Forest, US.
Last cleared in 2023. Active since 2001.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Ora, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
20 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
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
Cleared
Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
Ophthalmic
254d
Cleared
Feb 19, 2014
RS-3000 ADVANCE
Ophthalmic
209d
Cleared
Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
Ophthalmic
268d
Cleared
Oct 31, 2013
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE...
General & Plastic Surgery
128d
Cleared
Mar 14, 2013
NIDEK RS-3000
Ophthalmic
286d
Cleared
Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Ophthalmic
57d
Cleared
May 06, 2008
OPHTHALMOSCOPE F-10
Ophthalmic
266d
Cleared
Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
Ophthalmic
140d