Nidek, Inc.
Nidek, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2005, with 21 FDA device recalls on record.
Top product codes for Nidek, Inc.
FDA recalls by Nidek, Inc.
10 most recent of 21- Z-0771-2020 — 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 number of endothelial cells, cell density, and cell area is analyzed through the captured images.
- Z-0655-2019 — RT-5100 Refractor, a component of the Epic-5100 System.
- Z-1348-2018 — AUTO REF/KERATOMETER ARK-1s
- Z-1494-2017 — 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 system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
- Z-2711-2016 — 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 shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
- Z-2587-2016 — 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 cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
- Z-1245-2016 — 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 determining refractive error and binocular functions.
- Z-2477-2015 — 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 is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
- Z-2068-2015 — 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 ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
- Z-2067-2015 — 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 photocoagulation, iridotomy and trabeculoplasty.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nidek, Inc.
- K050336 — OPD-STATION SOFTWARE
- K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
- K031733 — NON-CONTACT TONOMETER, MODEL NT-4000
- K032085 — GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
- K013694 — NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
- K020876 — ECHOSCAN, MODEL US-1800
- K014274 — NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
- K013760 — DC-3300 LASER DIODE PHOTOCOAGULATOR
- K013864 — MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
- K990119 — EPI-STAR SURGICAL LASER SYSTER
- K990900 — MICROKERATOME, MODEL MK-2000
- K991284 — ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
- K980475 — UNIPULSE CO2 SURGICAL LASER SYSTEM
- K982295 — NIDEK LIGHTSCAN
- K981447 — DIO-LIGHT 60 LASER SYSTEM
- K980547 — NIDEK PRIMA MODEL GYC-1500/2000
- K974732 — NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
- K980201 — DIO-LIGHT LASER SYSTEM
- K973828 — PRIMA KTP LASER SYSTEM
- K973218 — NIDEK HANDY
- K973533 — NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
- K970017 — NIDEK CYBERSCAN
- K964353 — CYBERLASE CO2 LASER SYSTEM
- K960287 — HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
- K951079 — NIDEK MODEL GYC-1500 AND GYC-2000
- K951824 — STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
- K936302 — NIDEK MODEL VT-4000, MODIFICATION
- K932836 — NIDEK MODEL AC-2300
- K924353 — NIDEK MODEL VST-4000
- K924260 — NIDEK CV-12000
- K912384 — DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
- K913465 — NIDEK MODELS AC-2100 & 2200
- K913189 — NIDEK MODEL NT-1000
- K903639 — NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
- K904402 — NIDEK INC. MODEL AC-2000 DERM
- K903326 — NIDEK US-2000
- K902411 — NIDEK US-2500 W/BIOMETRY UNIT US-2520
- K900890 — NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
- K900925 — NIDEK, INC. MODEL ADC-8000 DERM
- K902500 — AR-1600G AUTO-REFRACTOMETER
- K901481 — MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
- K901513 — NIDEK RT-1200S (MARCO TRS-1200)
- K901686 — NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
- K900166 — NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
- K900165 — NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
- K895196 — MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
- K894709 — NIDEK MODEL ADC-8000
- K893987 — NIDEK MODEL YC-1200
- K894273 — NIDEK MODEL AKC-8000
- K892204 — NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
- K890559 — NIDEK AR-1200
- K875134 — OMRON ULTRASONIC NEBULIZER NE-U06
- K884188 — NIDEK LM-870 AUTOMATIC LENSMETER
- K883213 — NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
- K882162 — NIDEK US-3000
- K882191 — NIDEK ARK-2000
- K880929 — NIDEK CV-4000
- K880065 — NIDEK UP-2000
- K872846 — NIDEK ADC-8000 LASER SYSTEM
- K862137 — NIDEK KM-1000 SURGICAL KERATOMETER
- K861064 — LM-850 AUTOMATIC LENSMETER
- K861065 — AR-1100 AUTOMATIC REFRACTOR
- K854389 — NIDEK US-1600 A-SCAN
- K861062 — AR-1600 AUTOMATIC REFRACTOR
- K861063 — NIDEK KM-800 AUTO KERATOMETER
- K861066 — AR-1000 AUTOMATIC REFRACTOR
- K860011 — NIDEK AC-2000 LASER SYSTEM
- K843596 — NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
- K843597 — NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
- K844971 — MONOCULAR DIRECT OPHTHALMOSCOPE
- K844197 — ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
- K844198 — ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
- K842892 — NIDEK DIGITAL KERATOMETER
- K834305 — ARGON/KRYPTON ION LASER PHOTOCOAGULA
- K832331 — US-1000 ULTRASONIC IMAGING SYSTEM
- K831084 — SUN PHOTO-KERATOSCOPE
- K831083 — AUTO REFRACTOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.