Profile: Nidek, Inc. offers a wide array of equipment designed for the diagnosis and treatment of retinal diseases, glaucoma, and other vision-impairing afflictions. Our compact and reliable GYC-1000, solid-state laser photocoagulator, offers the highest level of performance and versatility available. The unique GYC-1000 offers multiple delivery options including slit lamps, binocular indirect ophthalmoscope, and end photocoagulation. It features diode pumped solid-state laser for extended life and efficiency at low-heat emission. It has detachable control panel for greater ease of use and convenience. We offer auto focus fundus camera. Our three-in-one Confoscan4 is auto-aligning and is not affected by corneal haze and opacities. The one-of-a-kind Confoscan4 also includes automatic cell-analysis software that detects the number of sides and area of each cell, as well as endothelial cell density.

FDA Registration Number: 2936921

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• AC- powered Corneal Topographers (FDA Code: MMQ / 886.1350) A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

• AC-Powered Automatic Perimeter (FDA Code: HPT / 886.1605) A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

• AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO / 886.1850) An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

• AC-Powered Keratome (FDA Code: HNO / 886.4370) A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

• AC-Powered Keratoscope (FDA Code: HLQ / 886.1350)

• AC-Powered Lens Measurment Instrument (FDA Code: HLM / 886.1425) A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

• AC-Powered Ophthalmic Camera (FDA Code: HKI / 886.1120) An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

• AC-Powered Tonometer (FDA Code: HKX / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

• Autofocus Fundus Cameras

• Binocular Indirect Ophthalmoscopes

• Biofeedback Systems

• CO2 Surgical Laser System

• Combo Lasers

• Confocal Microscopes

• Confocal Scanning Laser Ophthalmoscope (FDA Code: MYC / 886.1570) An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

• Corneal Radius Measurement Instrument (FDA Code: HJB / 886.1450) A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

• Corneal Topographers

• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100) A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Excimer Laser Systems

• Exophthalmometers (FDA Code: HLS / 886.1270) An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

• Eye Movement Monitor (FDA Code: HLL / 886.1510) An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

• Fundus Imagers

• Green photocoagulator Laser

• HF Pure Water

• Manual Non Powered Refractor with Phoropter (FDA Code: HKN / 886.1770) A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.

• Manual Pupillometer (FDA Code: HLH / 886.1700) A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

• Microperimeters

• Multicolor Lasers

• Ophthalmic Aberrometer (FDA Code: NCF / 886.1760) An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

• Ophthalmic Excimer Laser System (FDA Code: LZS)

• Ophthalmic Image Management System (FDA Code: NFJ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Ophthalmic Images Storage Device (FDA Code: NFF / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• Ophthalmic Lasers (FDA Code: HQF / 886.4390) An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

• Ophthalmic Lens Radius Measuring Device (FDA Code: HLF / 886.1430) An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.

• Ophthalmic Photodisruptors

• Ophthalmic Posterior Neodymium:yag Laser (FDA Code: LXS / 886.4392) The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.

• Ophthalmic Refractometer (FDA Code: HKO / 886.1760)

• Optometry Instruments

• Pachymeters (Pachometers), Ultrasonic Pachymetry

• Phacofragmentation Unit (FDA Code: HQC / 886.4670) A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

• Photocoagulator and Accessories (FDA Code: HQB / 886.4690) An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.

• Powered Ophthalmic Instrument Table (FDA Code: HRJ / 886.4855) An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• Solid-State Laser Photocoagulators

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Used Surgical Lasers

• Vision-Assessment Systems

• Visual Acuity Charts (FDA Code: HOX / 886.1150) A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.

• Wavefront Aberrometer