Company ยท US
Nidek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2023. Name variants (Inc, Corp, punctuation) are merged.
98510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 26 |
| HQF | Laser, Ophthalmic | 17 |
| HKO | Refractometer, Ophthalmic | 10 |
| HKI | Camera, Ophthalmic, Ac-Powered | 7 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 |
| HQB | Photocoagulator And Accessories | 5 |
| NQE | Microscope, Specular | 5 |
| HLQ | Keratoscope, Ac-Powered | 4 |
| HQC | Unit, Phacofragmentation | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 3 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | 3 |
| HLI | Ophthalmoscope, Ac-Powered | 3 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 3 |
| LZS | Excimer Laser System | 3 |
| OBO | Tomography, Optical Coherence | 3 |
| HKX | Tonometer, Ac-Powered | 2 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 2 |
| NFJ | System, Image Management, Ophthalmic | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2023 | K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Nidek Co., Ltd., JP | OBO |
| Dec 7, 2020 | K203130 | Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd., JP | HQF |
| Nov 15, 2019 | K192045 | Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd., JP | HQF |
| Apr 1, 2019 | K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S Nidek Co., Ltd., JP | HKI |
| Jul 19, 2018 | K181345 | Image Filing Software NAVIS-EX Nidek Co., Ltd., JP | NFJ |
| Mar 14, 2018 | K173980 | Specular Microscope CEM-530 Nidek Co., Ltd., JP | NQE |
| Jun 23, 2017 | K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 Nidek Co., Ltd., JP | HQF |
| May 19, 2017 | K163564 | SLIT LAMP SL-2000 Nidek Co., Ltd., JP | HJO |
| Jun 6, 2016 | K152729 | MICROPERIMETER MP-3 Nidek Co., Ltd., JP | HKI |
| May 2, 2016 | K152603 | Green Laser Photocoagulator GYC-500 Nidek Co., Ltd., JP | HQF |
| Mar 17, 2016 | K151706 | Specular Microscope CEM- 530 Nidek Co., Ltd., JP | NQE |
| Aug 12, 2014 | K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT Nidek Co., Ltd., IT | HQF |
| Jun 11, 2014 | K133132 | OPTICAL BIOMETER AL-SCAN Nidek Co., Ltd. | HJO |
| Feb 19, 2014 | K132323 | RS-3000 ADVANCE Nidek Co., Ltd. | OBO |
| Nov 27, 2013 | K130565 | SPECULAR MICROSCOPE CEM-530 Nidek Co., Ltd. | NQE |
| Oct 31, 2013 | K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT Nidek Co., Ltd., JP | GEX |
| Mar 14, 2013 | K121622 | NIDEK RS-3000 Nidek Co., Ltd. | OBO |
| Jul 27, 2011 | K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI Nidek Co., Ltd. | HQB |
| Feb 23, 2011 | K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated | HQB |
| May 6, 2008 | K072259 | OPHTHALMOSCOPE F-10 Nidek Co., Ltd. | MYC |
| Aug 24, 2005 | K050336 | OPD-STATION SOFTWARE Nidek, Inc. | NCF |
| Dec 14, 2004 | K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 Nidek, Inc. | GEX |
| Dec 4, 2003 | K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 Nidek, Inc. | HKX |
| Oct 3, 2003 | K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 Nidek, Inc. | GEX |
| Nov 19, 2002 | K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) Nidek, Inc. | NFJ |
| May 3, 2002 | K020876 | ECHOSCAN, MODEL US-1800 Nidek, Inc. | IYO |
| Apr 17, 2002 | K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 Nidek, Inc. | HKI |
| Feb 11, 2002 | K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR Nidek, Inc. | HQF |
| Feb 8, 2002 | K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 Nidek, Inc. | GEX |
| Mar 9, 2001 | K003299 | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 Nidek Co., Ltd. | HLQ |
| Jul 27, 2000 | K990119 | EPI-STAR SURGICAL LASER SYSTER Nidek, Inc. | GEX |
| Sep 24, 1999 | K990900 | MICROKERATOME, MODEL MK-2000 Nidek, Inc. | HNO |
| Aug 6, 1999 | K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM Nidek, Inc. | MXK |
| Dec 16, 1998 | K980475 | UNIPULSE CO2 SURGICAL LASER SYSTEM Nidek, Inc. | GEX |
| Aug 6, 1998 | K982295 | NIDEK LIGHTSCAN Nidek, Inc. | GEX |
| Jun 5, 1998 | K981447 | DIO-LIGHT 60 LASER SYSTEM Nidek, Inc. | GEX |
| May 13, 1998 | K980547 | NIDEK PRIMA MODEL GYC-1500/2000 Nidek, Inc. | GEX |
| Mar 18, 1998 | K974732 | NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 Nidek, Inc. | GEX |
| Mar 16, 1998 | K980201 | DIO-LIGHT LASER SYSTEM Nidek, Inc. | GEX |
| Jan 5, 1998 | K973828 | PRIMA KTP LASER SYSTEM Nidek, Inc. | GEX |
| Nov 4, 1997 | K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) Nidek, Inc. | HKI |
| Nov 4, 1997 | K973218 | NIDEK HANDY Nidek, Inc. | HKI |
| Mar 18, 1997 | K970017 | NIDEK CYBERSCAN Nidek, Inc. | GEX |
| Feb 28, 1997 | K964353 | CYBERLASE CO2 LASER SYSTEM Nidek, Inc. | GEX |
| Nov 5, 1996 | K960287 | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM Nidek, Inc. | HQC |
| Sep 14, 1995 | K951079 | NIDEK MODEL GYC-1500 AND GYC-2000 Nidek, Inc. | HQF |
| Jul 19, 1995 | K951824 | STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) Nidek, Inc. | HQC |
| Jul 15, 1994 | K936302 | NIDEK MODEL VT-4000, MODIFICATION Nidek, Inc. | HQE |
| Nov 22, 1993 | K932836 | NIDEK MODEL AC-2300 Nidek, Inc. | HQF |
| Mar 29, 1993 | K924353 | NIDEK MODEL VST-4000 Nidek, Inc. | HQE |
Newest 50 of 98.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2019 | Nidek, Inc. NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Informati Terminated |
NQE | K130565 K151706 +1 |
| Jun 14, 2018 | Nidek Inc. RT-5100 Refractor, a component of the Epic-5100 System. Terminated |
HKN | None listed |
| Dec 20, 2017 | Nidek Inc. AUTO REF/KERATOMETER ARK-1s Terminated |
HKO | None listed |
| Feb 1, 2017 | Nidek Inc Final Fit Software Version 1.11 and 1.12;
PC Based software installed outside Nidek EC-5000 Excimer Laser System.
Ophthalmic laser system use for correction of corneal refraction and ablation of th Terminated |
LZS | None listed |
| Sep 1, 2016 | Nidek Inc SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.
Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observatio Terminated |
NQE | K151706 |
| Jul 1, 2016 | Nidek Inc OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.
Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the po Terminated |
HJO | K133132 |
| Mar 24, 2016 | Nidek Inc RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:
Product Usage:
Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects Terminated |
HKN | None listed |
| Aug 27, 2015 | Nidek Inc OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic
Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.
Opthal Terminated |
HKO | None listed |
| Jul 14, 2015 | Nidek Inc Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System;
GYC4EP-01 0W02 and GYC4EP-1 0Z20;
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in oph Terminated |
GEX | K032085 K133358 |
| Jul 14, 2015 | Nidek Inc Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system
GYC4DD-1:
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including re Terminated |
GEX | K032085 K133358 |
| Jun 4, 2015 | Nidek Inc EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.
Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for corre Terminated |
LZS | None listed |
| Apr 2, 2015 | Nidek Inc YC-1800 OPHTHALMIC YAG LASER SYSTEM;
The YC-1800 allows the safe and bloodless treatment of intraocular
diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. Terminated |
LXS | K893987 |
| Feb 19, 2015 | Nidek Inc MC-500 Multicolor Laser Photocoagulator;
Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy Terminated |
HQF | K110228 |
| Nov 17, 2014 | Nidek Inc Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation fo Terminated |
HQF | K110228 |
| Nov 17, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. Terminated |
HQF | K110228 |
| Nov 17, 2014 | Nidek Inc Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII.
Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam del Terminated |
LZS | None listed |
| Aug 13, 2014 | Nidek Inc GYC-1000 Green Laser Photocoagulator system
The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulatio Terminated |
GEX | K032085 |
| Jul 30, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. Terminated |
HQF | K110228 |
| Jul 2, 2014 | Nidek Inc Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye.
Distributed by Nidek, Inc, and Marco Opthalmic Inc. Terminated |
HKI | K113451 |
| Jun 23, 2014 | Nidek Inc RT-5100 Refractor and RT-3100 Refractor;
Distributed by MARCO Opthalmic:
Manufactured by NIDEK CO., Ltd., Aichi, Japan.
Instrument provides means of positioning spherical and cylindrical lenses, pri Terminated |
HKN | None listed |
| Aug 23, 2013 | Nidek Inc NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. Terminated |
HKI | K113451 |