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Data / Medical devices / Japan / Nidek Co., Ltd. Hamacho Plant

Nidek Co., Ltd. Hamacho Plant: FDA-registered device maker in Gamagori, Aichi, Japan, 20 510(k) clearances and 1 PMA approval

Nidek Co., Ltd. Hamacho Plant is registered with the FDA (registration 3002807715) in Gamagori, Aichi, Japan. It lists 25 device types. The FDA files 20 510(k) clearances and 1 PMA approval under its listings, the newest dated March 30, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Nidek Co., Ltd. Hamacho Plant
FDA registration number
3002807715
Address
67-4 Hama-Cho, Gamagori, Aichi, Japan, 4430036
Owner or operator
NIDEK CO., LTD. (8030392)
Roles
Exporter to the US, Manufacturer
First device listed
July 14, 1983
Registered through
2026
Brand names listed
PERIMETER

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Manufactureraccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Manufactureraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Manufactureraccessdata.fda.gov
Chart, Visual AcuityHOX1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Communications, Images, OphthalmicNFG1Manufactureraccessdata.fda.gov
Device, Storage, Images, OphthalmicNFF1Manufactureraccessdata.fda.gov
Excimer Laser SystemLZS3Manufactureraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Manufactureraccessdata.fda.gov
Keratoscope, Ac-PoweredHLQ1Manufactureraccessdata.fda.gov
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting PupillaLXS2Manufactureraccessdata.fda.gov
Laser, OphthalmicHQF2Manufactureraccessdata.fda.gov
Microscope, SpecularNQE2Manufactureraccessdata.fda.gov
Ophthalmoscope, Laser, ScanningMYC2Manufactureraccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Manufactureraccessdata.fda.gov
Photocoagulator And AccessoriesHQB2Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.fda.gov
Pupillometer, Ac-PoweredHLG1Manufactureraccessdata.fda.gov
Refractometer, OphthalmicHKO1Manufactureraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Exporter to the US, Manufactureraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Manufactureraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Manufactureraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 30, 2023K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXOBOSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
December 7, 2020K203130Ophthalmic Yag Laser System YC-200HQFSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
November 15, 2019K192045Ophthalmic Yag Laser System YC-200HQFSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
April 1, 2019K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKISubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
July 19, 2018K181345Image Filing Software NAVIS-EXNFJSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
March 14, 2018K173980Specular Microscope CEM-530NQESubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
June 23, 2017K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQFSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
June 6, 2016K152729MICROPERIMETER MP-3HKISubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
May 2, 2016K152603Green Laser Photocoagulator GYC-500HQFSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
March 17, 2016K151706Specular Microscope CEM- 530NQESubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
August 12, 2014K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQFSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
June 11, 2014K133132OPTICAL BIOMETER AL-SCANHJOSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
November 27, 2013K130565SPECULAR MICROSCOPE CEM-530NQESubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
May 8, 2012K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKISubstantially EquivalentNidek Technologies Srlaccessdata.fda.gov
July 27, 2011K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQBSubstantially EquivalentNidek Co., Ltd.accessdata.fda.gov
February 23, 2011K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQBSubstantially EquivalentNidek Incorporatedaccessdata.fda.gov
September 28, 2006K061768MP-1 MICROPERIMETERHKISubstantially EquivalentNidek Technologies Srlaccessdata.fda.gov
December 4, 2003K031733NON-CONTACT TONOMETER, MODEL NT-4000HKXSubstantially EquivalentNidek, Inc.accessdata.fda.gov
May 3, 2002K020876ECHOSCAN, MODEL US-1800IYOSubstantially EquivalentNidek, Inc.accessdata.fda.gov
August 18, 1989K893987NIDEK MODEL YC-1200LXSSubstantially EquivalentNidek, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
December 17, 1998P970053EC-5000 EXCIMER LASER SYSTEMLZS16January 12, 2018accessdata.fda.gov

Compare with other makers

Updated March 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.