Medical Device Manufacturer · US , Lake Forest , CA

Nidek Co., Ltd. - FDA 510(k) Cleared Devices

20 submissions · 19 cleared · Since 2001
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.

FDA 510(k) Regulatory Record - Nidek Co., Ltd.
20 devices
1-20 of 20
Cleared CT Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
K221320 · OBO
Ophthalmic · 328d
Cleared Dec 07, 2020
Ophthalmic Yag Laser System YC-200
K203130 · HQF
Ophthalmic · 49d
Cleared Nov 15, 2019
Ophthalmic Yag Laser System YC-200
K192045 · HQF
Ophthalmic · 107d
Cleared Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198 · HKI
Ophthalmic · 56d
Cleared Jul 19, 2018
Image Filing Software NAVIS-EX
K181345 · NFJ
Ophthalmic · 59d
Cleared Mar 14, 2018
Specular Microscope CEM-530
K173980 · NQE
Ophthalmic · 75d
Cleared Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
K170302 · HQF
Ophthalmic · 143d
Cleared May 19, 2017
SLIT LAMP SL-2000
K163564 · HJO
Ophthalmic · 151d
Cleared Jun 06, 2016
MICROPERIMETER MP-3
K152729 · HKI
Ophthalmic · 258d
Cleared May 02, 2016
Green Laser Photocoagulator GYC-500
K152603 · HQF
Ophthalmic · 234d
Cleared Mar 17, 2016
Specular Microscope CEM- 530
K151706 · NQE
Ophthalmic · 267d
Cleared Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
K133358 · HQF
Ophthalmic · 285d
Cleared Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
K133132 · HJO
Ophthalmic · 254d
Cleared Feb 19, 2014
RS-3000 ADVANCE
K132323 · OBO
Ophthalmic · 209d
Cleared Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
K130565 · NQE
Ophthalmic · 268d
Cleared Oct 31, 2013
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE...
K131894 · GEX
General & Plastic Surgery · 128d
Cleared Mar 14, 2013
NIDEK RS-3000
K121622 · OBO
Ophthalmic · 286d
Cleared Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · HQB
Ophthalmic · 57d
Cleared May 06, 2008
OPHTHALMOSCOPE F-10
K072259 · MYC
Ophthalmic · 266d
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ
Ophthalmic · 140d
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