Medical Device Manufacturer · US , Lake Forest , CA

Nidek Co., Ltd.

20 submissions · 19 cleared · Since 2001
20
Total
19
Cleared
0
Denied

Nidek Co., Ltd. — FDA 510(k) Submissions

Nidek Co., Ltd. has submitted 20 FDA 510(k) premarket notifications since 2001, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laser, Ophthalmic, Tomography, Optical Coherence, Microscope, Specular, Biomicroscope, Slit-lamp, Ac-powered, Camera, Ophthalmic, Ac-powered . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
K221320 · OBO Tomography, Optical... · Ophthalmic
Mar 2023 328d
Ophthalmic Yag Laser System YC-200
K203130 · HQF Laser, Ophthalmic · Ophthalmic
Dec 2020 49d
Ophthalmic Yag Laser System YC-200
K192045 · HQF Laser, Ophthalmic · Ophthalmic
Nov 2019 107d
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198 · HKI Camera, Ophthalmic,... · Ophthalmic
Apr 2019 56d
Image Filing Software NAVIS-EX
K181345 · NFJ System, Image Management,... · Ophthalmic
Jul 2018 59d
Specular Microscope CEM-530
K173980 · NQE Microscope, Specular · Ophthalmic
Mar 2018 75d
YELLOW LASER PHOTOCOAGULATOR YLC-500
K170302 · HQF Laser, Ophthalmic · Ophthalmic
Jun 2017 143d
SLIT LAMP SL-2000
K163564 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
May 2017 151d
MICROPERIMETER MP-3
K152729 · HKI Camera, Ophthalmic,... · Ophthalmic
Jun 2016 258d
Green Laser Photocoagulator GYC-500
K152603 · HQF Laser, Ophthalmic · Ophthalmic
May 2016 234d
Specular Microscope CEM- 530
K151706 · NQE Microscope, Specular · Ophthalmic
Mar 2016 267d
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
K133358 · HQF Laser, Ophthalmic · Ophthalmic
Aug 2014 285d
OPTICAL BIOMETER AL-SCAN
K133132 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Jun 2014 254d
RS-3000 ADVANCE
K132323 · OBO Tomography, Optical... · Ophthalmic
Feb 2014 209d
SPECULAR MICROSCOPE CEM-530
K130565 · NQE Microscope, Specular · Ophthalmic
Nov 2013 268d
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
K131894 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2013 128d
NIDEK RS-3000
K121622 · OBO Tomography, Optical... · Ophthalmic
Mar 2013 286d
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · HQB Photocoagulator And... · Ophthalmic
Jul 2011 57d
OPHTHALMOSCOPE F-10
K072259 · MYC Ophthalmoscope, Laser,... · Ophthalmic
May 2008 266d
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ Keratoscope, Ac-powered · Ophthalmic
Mar 2001 140d
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