Data / Medical devices / United States / Nidek Incorporated
Nidek Incorporated: FDA-registered device maker in The Colony, TX, United States, 20 510(k) clearances and 1 PMA approval
Nidek Incorporated is registered with the FDA (registration 2936921) in The Colony, TX, United States. 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. 20 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2936921
- Address
- 6601 Cascades Court Suite 130, The Colony, TX, United States, 75056
- Owner or operator
- NIDEK CO., LTD. (8030392)
- Roles
- Manufacturer
- First device listed
- July 14, 1983
- Registered through
- 2027
- Brand names listed
- PERIMETER
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2023 | K221320 | 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 | OBO | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| December 7, 2020 | K203130 | Ophthalmic Yag Laser System YC-200 | HQF | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| November 15, 2019 | K192045 | Ophthalmic Yag Laser System YC-200 | HQF | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| April 1, 2019 | K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | HKI | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| July 19, 2018 | K181345 | Image Filing Software NAVIS-EX | NFJ | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| March 14, 2018 | K173980 | Specular Microscope CEM-530 | NQE | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| June 23, 2017 | K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | HQF | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| June 6, 2016 | K152729 | MICROPERIMETER MP-3 | HKI | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| May 2, 2016 | K152603 | Green Laser Photocoagulator GYC-500 | HQF | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| March 17, 2016 | K151706 | Specular Microscope CEM- 530 | NQE | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| August 12, 2014 | K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | HQF | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| June 11, 2014 | K133132 | OPTICAL BIOMETER AL-SCAN | HJO | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| November 27, 2013 | K130565 | SPECULAR MICROSCOPE CEM-530 | NQE | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX | HKI | Substantially Equivalent | Nidek Technologies Srl | accessdata.fda.gov |
| July 27, 2011 | K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | HQB | Substantially Equivalent | Nidek Co., Ltd. | accessdata.fda.gov |
| February 23, 2011 | K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | HQB | Substantially Equivalent | Nidek Incorporated | accessdata.fda.gov |
| September 28, 2006 | K061768 | MP-1 MICROPERIMETER | HKI | Substantially Equivalent | Nidek Technologies Srl | accessdata.fda.gov |
| December 4, 2003 | K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | HKX | Substantially Equivalent | Nidek, Inc. | accessdata.fda.gov |
| May 3, 2002 | K020876 | ECHOSCAN, MODEL US-1800 | IYO | Substantially Equivalent | Nidek, Inc. | accessdata.fda.gov |
| August 18, 1989 | K893987 | NIDEK MODEL YC-1200 | LXS | Substantially Equivalent | Nidek, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 17, 1998 | P970053 | EC-5000 EXCIMER LASER SYSTEM | LZS | 16 | January 12, 2018 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2019 | 84112 | Class III | Terminated | 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. Information such as the numbe | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) | accessdata.fda.gov |
| June 14, 2018 | 81529 | Class III | Terminated | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | accessdata.fda.gov |
| December 20, 2017 | 79553 | Class II | Terminated | AUTO REF/KERATOMETER ARK-1s | There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. | accessdata.fda.gov |
| February 1, 2017 | 76376 | Class II | Terminated | 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 the corneal surface. The | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | accessdata.fda.gov |
| August 8, 2016 | 74900 | Class II | Terminated | 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 observation of the size and sha | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. | accessdata.fda.gov |
| July 1, 2016 | 74595 | Class II | Terminated | 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 power of an IOL for cat | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. | accessdata.fda.gov |
| February 29, 2016 | 73316 | Class II | Terminated | 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 eye for purpose of d | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient. | accessdata.fda.gov |
| June 15, 2015 | 71691 | Class II | Terminated | 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. Opthalmic: The OPD-Scan III | Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. | accessdata.fda.gov |
| March 25, 2015 | 71527 | Class II | Terminated | 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 retinal and macular pho | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | accessdata.fda.gov |
| March 24, 2015 | 71098 | Class II | Terminated | 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 correction of corneal refr | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | accessdata.fda.gov |
| March 6, 2015 | 70571 | Class II | Terminated | 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. | Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images. | accessdata.fda.gov |
| June 16, 2014 | 68234 | Class II | Terminated | 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. Manufactured by Nidek C | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. | accessdata.fda.gov |
| June 9, 2014 | 68766 | Class II | Terminated | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. | Laser aperture label was not affixed to device prior to shipment in the US. | accessdata.fda.gov |
| June 9, 2014 | 68485 | Class II | Terminated | 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, prisms and other optical | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. | accessdata.fda.gov |
| May 16, 2014 | 68302 | Class II | Terminated | 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 photocoagulation, iridotomy and trab | Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation | accessdata.fda.gov |
| August 1, 2013 | 65865 | Class II | Terminated | 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. | Under certain circumstances, the Left eye image may be saved as the Right eye image. | accessdata.fda.gov |
| May 24, 2013 | 69531 | Class II | Terminated | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. | accessdata.fda.gov |
| October 24, 2012 | 69537 | Class II | Terminated | 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 for treatment of ocula | When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. | accessdata.fda.gov |
| August 6, 2012 | 69508 | Class II | Terminated | 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 delivery unit, an optic | Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient. | accessdata.fda.gov |
| March 27, 2012 | 70335 | Class II | Terminated | 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 of prematurity and r | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. | accessdata.fda.gov |
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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.