Nidek, Inc.
Medical device manufacturer in Gamagori, JP.
98510(k) clearances
2PMA approvals
21recalls
Device types
- GEX Powered Laser Surgical Instrument 23
- HQF Laser, Ophthalmic 13
- HKO Refractometer, Ophthalmic 8
- IYO System, Imaging, Pulsed Echo, Ultrasonic 7
- HQB Photocoagulator And Accessories 5
- HKI Camera, Ophthalmic, Ac-Powered 5
- HLQ Keratoscope, Ac-Powered 4
- HQE Instrument, Vitreous Aspiration And… 4
- HQC Unit, Phacofragmentation 4
- OBO Tomography, Optical Coherence 3
- NQE Microscope, Specular 3
- HLI Ophthalmoscope, Ac-Powered 3
- LXS Laser, Neodymium:Yag, Ophthalmic For… 2
- HKX Tonometer, Ac-Powered 2
- HLM Instrument, Measuring, Lens, Ac-Powered 2
- NFJ System, Image Management, Ophthalmic 2
- HJO Biomicroscope, Slit-Lamp, Ac-Powered 2
- CAF Nebulizer (Direct Patient Interface) 1
- MXK Device, Analysis, Anterior Segment 1
- HNO Keratome, Ac-Powered 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…OBO · Traditional | 03/30/2023SE |
| K203130 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 12/07/2020SE |
| K192045 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 11/15/2019SE |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type SHKI · Traditional | 04/01/2019SE |
| K181345 | Image Filing Software NAVIS-EXNFJ · Traditional | 07/19/2018SE |
| K173980 | Specular Microscope CEM-530NQE · Traditional | 03/14/2018SE |
| K170302 | Yellow Laser Photocoagulator YLC-500HQF · Traditional | 06/23/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | 05/19/2017SE |
| K152729 | Microperimeter MP-3HKI · Traditional | 06/06/2016SE |
| K152603 | Green Laser Photocoagulator GYC-500HQF · Traditional | 05/02/2016SE |
| K151706 | Specular Microscope CEM- 530NQE · Traditional | 03/17/2016SE |
| K133358 | Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…HQF · Traditional | 08/12/2014SE |
| K133132 | Optical Biometer Al-ScanHJO · Traditional | 06/11/2014SE |
| K132323 | RS-3000 AdvanceOBO · Traditional | 02/19/2014SE |
| K130565 | Specular Microscope CEM-530NQE · Traditional | 11/27/2013SE |
| K131894 | Nidek Green Laser Photocoagultor Model GYC-1000 Connected with the Endophotocoagulation…GEX · Special | 10/31/2013SE |
| K121622 | Nidek RS-3000OBO · Traditional | 03/14/2013SE |
| K111493 | Nidek Multicolor Scan Laser Photocoagulator MC-500 VixiHQB · Traditional | 07/27/2011SE |
| K110228 | Nidek Multicolor Laser PhotocoagulatorHQB · Special | 02/23/2011SE |
| K072259 | Ophthalmoscope F-10MYC · Abbreviated | 05/06/2008SE |
| K050336 | Opd-Station SoftwareNCF · Traditional | 08/24/2005SE |
| K042785 | Multi Color Laser Photocoagulator, Model MC-300GEX · Traditional | 12/14/2004SE |
| K031733 | Non-Contact Tonometer, Model NT-4000HKX · Traditional | 12/04/2003SE |
| K032085 | Green Laser Photocoagulator Model GYC-1000GEX · Traditional | 10/03/2003SE |
| K013694 | Nidek Advanced Vision Information System (Navis)NFJ · Traditional | 11/19/2002SE |
| K020876 | Echoscan, Model US-1800IYO · Special | 05/03/2002SE |
| K014274 | Non-Mydriatic Fundus Camera, Model NM-1000HKI · Traditional | 04/17/2002SE |
| K013760 | DC-3300 Laser Diode PhotocoagulatorHQF · Traditional | 02/11/2002SE |
| K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60GEX · Traditional | 02/08/2002SE |
| K003299 | Opd-Scan, Models ARK-10000 and ARK-9000HLQ · Traditional | 03/09/2001SESU |
| K990119 | Epi-Star Surgical Laser SysterGEX · Traditional | 07/27/2000SE |
| K990900 | Microkeratome, Model MK-2000HNO · Traditional | 09/24/1999SE |
| K991284 | Anterior Eye-Segment Analysis SystemMXK · Traditional | 08/06/1999SE |
| K980475 | Unipulse CO2 Surgical Laser SystemGEX · Traditional | 12/16/1998SE |
| K982295 | Nidek LightscanGEX · Traditional | 08/06/1998SE |
| K981447 | Dio-Light 60 Laser SystemGEX · Traditional | 06/05/1998SE |
| K980547 | Nidek Prima Model GYC-1500/2000GEX · Traditional | 05/13/1998SE |
| K974732 | Nidek Multi Color Laser Photocoagulator, Model MC-7000GEX · Traditional | 03/18/1998SE |
| K980201 | Dio-Light Laser SystemGEX · Traditional | 03/16/1998SE |
| K973828 | Prima KTP Laser SystemGEX · Traditional | 01/05/1998SE |
| K973533 | Nidek Stereo Disc CAMERA(3-DX)/NIDEK Stereo Fundus CAMERA(3-DXF)HKI · Traditional | 11/04/1997SE |
| K973218 | Nidek HandyHKI · Traditional | 11/04/1997SE |
| K970017 | Nidek CyberscanGEX · Traditional | 03/18/1997SE |
| K964353 | Cyberlase CO2 Laser SystemGEX · Traditional | 02/28/1997SE |
| K960287 | Handpiece for Nidek CV-12000 Phaco SystemHQC · Traditional | 11/05/1996SE |
| K951079 | Nidek Model GYC-1500 and GYC-2000HQF · Traditional | 09/14/1995SE |
| K951824 | Storz Microseal Phacoemulsification Needles (Importation)HQC · Traditional | 07/19/1995SE |
| K936302 | Nidek Model VT-4000, ModificationHQE · Traditional | 07/15/1994SE |
| K932836 | Nidek Model AC-2300HQF · Traditional | 11/22/1993SE |
| K924353 | Nidek Model VST-4000HQE · Traditional | 03/29/1993SE |
| K924260 | Nidek CV-12000HQC · Traditional | 03/26/1993SE |
| K912384 | Disposable Supplies Kit for Pea ProcedureHQE · Traditional | 12/24/1991SE |
| K913465 | Nidek Models AC-2100 & 2200GEX · Traditional | 10/21/1991SE |
| K913189 | Nidek Model NT-1000HKX · Traditional | 10/15/1991SE |
| K903639 | Nidek DC-3000 Diode Laser PhotocoagulatorGEX · Traditional | 02/04/1991SE |
| K904402 | Nidek Inc. Model AC-2000 DermGEX · Traditional | 12/07/1990SE |
| K903326 | Nidek US-2000IYO · Traditional | 11/21/1990SE |
| K902411 | Nidek US-2500 W/Biometry Unit US-2520IYO · Traditional | 10/09/1990SE |
| K900925 | Nidek, Inc. Model ADC-8000 DermGEX · Traditional | 09/10/1990SE |
| K900890 | Nidek Model AKC-8000 Ophthalmic Laser PhotocoagulaGEX · Traditional | 09/10/1990SE |
| K902500 | AR-1600G Auto-RefractometerHKO · Traditional | 07/27/1990SE |
| K901481 | Model YC-1200/PHOTOCOAGULATOR Ophthalmic LaserGEX · Traditional | 06/20/1990SE |
| K901686 | Nidek/Phaco Emulsification System Model CV-8000HQC · Traditional | 06/08/1990SE |
| K901513 | Nidek RT-1200S (Marco TRS-1200)HKO · Traditional | 06/08/1990SE |
| K900166 | Nidek, Inc. Models YC-1100 Ophthalmic LasersGEX · Traditional | 03/27/1990SE |
| K900165 | Nidek, Inc. Bio-Dc Laser Delivery SystemGEX · Traditional | 03/22/1990SE |
| K895196 | Model DC-1200 Diode Laser PhotocoagulatorHQF · Traditional | 10/16/1989SE |
| K894709 | Nidek Model ADC-8000GEX · Traditional | 10/04/1989SE |
| K893987 | Nidek Model YC-1200LXS · Traditional | 08/18/1989SE |
| K894273 | Nidek Model AKC-8000HQF · Traditional | 08/07/1989SE |
| K892204 | Nidek Inc. Models YC-2000 & 3000 Ophthalmic LasersLXS · Traditional | 06/22/1989SE |
| K890559 | Nidek AR-1200HKO · Traditional | 02/27/1989SE |
| K875134 | Omron Ultrasonic Nebulizer NE-U06CAF · Traditional | 12/05/1988SE |
| K884188 | Nidek LM-870 Automatic LensmeterHLM · Traditional | 11/23/1988SE |
| K883213 | Nidek Opeating Microscope Delivery System (Omds)HQF · Traditional | 09/15/1988SE |
| K882162 | Nidek US-3000IYO · Traditional | 08/19/1988SE |
| K882191 | Nidek ARK-2000HKO · Traditional | 07/01/1988SE |
| K880929 | Nidek CV-4000HQE · Traditional | 05/25/1988SE |
| K880065 | Nidek UP-2000IYO · Traditional | 03/15/1988SE |
| K872846 | Nidek ADC-8000 Laser SystemHQF · Traditional | 10/15/1987SE |
| K862137 | Nidek KM-1000 Surgical KeratometerHLQ · Traditional | 07/23/1986SE |
| K861064 | LM-850 Automatic LensmeterHLM · Traditional | 04/15/1986SE |
| K861065 | AR-1100 Automatic RefractorHKO · Traditional | 04/09/1986SE |
| K854389 | Nidek US-1600 A-ScanIYO · Traditional | 04/08/1986SE |
| K861066 | AR-1000 Automatic RefractorHKO · Traditional | 04/04/1986SE |
| K861063 | Nidek KM-800 Auto KeratometerHLQ · Traditional | 04/04/1986SE |
| K861062 | AR-1600 Automatic RefractorHKO · Traditional | 04/04/1986SE |
| K860011 | Nidek AC-2000 Laser SystemHQB · Traditional | 02/07/1986SE |
| K844971 | Monocular Direct OphthalmoscopeHLI · Traditional | 02/15/1985SE |
| K843597 | Nidek Monocular Indirect OphthalmoscopeHLI · Traditional | 02/15/1985SE |
| K843596 | Nidek-Binocular Indirect OphthalmoscopeHLI · Traditional | 02/15/1985SE |
| K844198 | Argon Laser Photocoagulator Sys Repeat ModeHQB · Traditional | 12/24/1984SE |
| K844197 | Argon/Krypton & Krypton Laser Photocoagulation SysHQB · Traditional | 12/24/1984SE |
| K842892 | Nidek Digital KeratometerHQL · Traditional | 10/05/1984SE |
| K834305 | Argon/Krypton Ion Laser PhotocoagulaHQF · Traditional | 03/16/1984SE |
| K832331 | US-1000 Ultrasonic Imaging SystemIYO · Traditional | 08/16/1983SE |
| K831084 | Sun Photo-KeratoscopeHLQ · Traditional | 06/30/1983SE |
| K831083 | Auto RefractometerHKO · Traditional | 06/10/1983SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0771-2020 Class III | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides…The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC… | 02/25/2019Terminated |
| Z-0655-2019 Class III | RT-5100 Refractor, a component of the Epic-5100 System.The lens bonding was incomplete on the refractor. | 06/14/2018Terminated |
| Z-1348-2018 Class II | AUTO REF/KERATOMETER ARK-1sThere is possibly a difference between the measured dioptric value of the subjective measurement mode and… | 12/20/2017Terminated |
| Z-1494-2017 Class II | Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek…During treatment planning, the procedure was programmed with an unintended (wrong) correction. | 02/01/2017Terminated |
| Z-2711-2016 Class II | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK…Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results… | 08/08/2016Terminated |
| Z-2587-2016 Class II | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL…Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much… | 07/01/2016Terminated |
| Z-1245-2016 Class II | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing…There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm… | 02/29/2016Terminated |
| Z-2477-2015 Class II | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08…Software bug was found where there was no difference in Total and Corneal high-order aberrations, but… | 06/15/2015Terminated |
| Z-2068-2015 Class II | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System…Accessories to the GYC-1000 laser were missing Laser Aperture labels. | 03/25/2015Terminated |
| Z-2067-2015 Class II | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek…Accessories to the GYC-1000 laser were missing Laser Aperture labels. | 03/25/2015Terminated |
| Z-1710-2015 Class II | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.…Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | 03/24/2015Terminated |
| Z-1367-2015 Class II | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment…Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important… | 03/06/2015Terminated |
| Z-1980-2014 Class II | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in…Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. | 06/16/2014Terminated |
| Z-2132-2014 Class II | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK…Laser aperture label was not affixed to device prior to shipment in the US. | 06/09/2014Terminated |
| Z-1853-2014 Class II | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by…Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient… | 06/09/2014Terminated |
| Z-2120-2014 Class II | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model…Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field… | 05/16/2014Terminated |
| Z-2046-2013 Class II | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5.…Under certain circumstances, the Left eye image may be saved as the Right eye image. | 08/01/2013Terminated |
| Z-0222-2015 Class II | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device…Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function… | 05/24/2013Terminated |
| Z-0224-2015 Class II | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic…When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery… | 10/24/2012Terminated |
| Z-0223-2015 Class II | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The…Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery… | 08/06/2012Terminated |
| Z-1127-2015 Class II | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation…The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by… | 03/27/2012Terminated |