Address:34-14 MAEHAMA, HIROISHI-CHO,GAMAGORI, AICHI,JP
Device Description : The Final Fit software receives the measured data from the Refractive Power/Corn The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
Device Class : 3
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is us The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewe The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, andthe toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NIDEK AUTO LENSMETER LM-7/LM-7P measures the optical performance of spectacl The NIDEK AUTO LENSMETER LM-7/LM-7P measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The NIDEK AUTO LENSMETER LM-7/LM-7P measures the optical performance of spectacl The NIDEK AUTO LENSMETER LM-7/LM-7P measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. LM-7P is equipped with a printer.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The TS-310 is a space-saving automated refraction system that uses a combination The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box.• With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances.• The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : No
Device Description : Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires da Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX.In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : Yes
Device Description : The RT-6100 is a motorized refractor for subjective refraction designed to be co The RT-6100 is a motorized refractor for subjective refraction designed to be connected with other Nidek products such as the Auto Refractometer and/or Lensmeter to import their measurement data. Measurement of refractive errors (spherical power, cylindrical power, and cylinder axis) and binocular visual function testing are performed according to the patient’s response.
Device Class : 1
Duns Number: 690635461
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system cons The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy.
Device Class : 2
Duns Number: 690635461
Premarket Exempt : No
Prescription Use : No