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Device Description : This combination delivery unit is need to comprise the combination system which This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laserbeam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted.The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NON CONTACT TONOMETER Model NT-510 is designed for non-contact tonometry mea The NON CONTACT TONOMETER Model NT-510 is designed for non-contact tonometry measurement. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Tonometry is performed for screening of glaucoma, and for preoperative examination and postoperativecare in ophthalmology.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NON CONTACT TONOMETER Model NT-530 is designed for non-contact tonometry mea The NON CONTACT TONOMETER Model NT-530 is designed for non-contact tonometry measurement. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Tonometry is performed for screening of glaucoma, and for preoperative examination and postoperativecare in ophthalmology.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : Ultrasonic waves are the sound waves pitched above the range of human hearing wh Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are applied, and these types of high sound waves have the following characteristics similar to light:They have a high tendency to travel in a straight direction. They have characteristics such as reflect.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length an The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis.Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera t The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer.In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features:• Image analysis functions such as 3D/map color display or retinal thickness analysis• Networking for data review or analysis on PCs in separate locations
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NAVIS-EX image filing software is software that acquires data from the follo The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the clientPC.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification i 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. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single 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. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement functionby touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such asaxial length.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes