News at NIDEK
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New YAG and SLT laser systems offer exact targeting and precise treatment
[San Jose, CA – 11/18/19] NIDEK is pleased to announce that the United States Food & Drug Administration (FDA) has issued 510(k) Clearance for the YC-200 Ophthalmic YAG Laser System. The YC-200 includes the S plus model for Selective Laser Trabeculoplasty (SLT). With FDA clearance, the YC-200 and YC-200 S plus are now commercially available in the USA.
NIDEK INC Takes on the Medmont E300 Corneal Topographer 09/02/2019
Medmont International Pty Ltd. and NIDEK INC are proud to announce its further partnership as of July 25, 2019.
NIDEK INC will now be offering the Medmont E300 Corneal Topographer to US Optometrists in addition to US Ophthalmologists and US Ophthalmic Government tendered competitions.
NIDEK INC Takes on the Medmont E300 Corneal Topographer 06/27/2017
Medmont International Pty Ltd. and NIDEK Inc. are proud to announce its partnership as of May 25, 2017
NIDEK Inc. will now be offering the Medmont E300 Corneal Topographer to US Ophthalmologists, and Ophthalmic Government tendered competitions.
About ransomware attack 06/01/2017
As reported in the media, ransomware* known as “Wanna Cryptor WannaCry”, “WannaCryptor”, or “Wcry” has caused damage to IT systems worldwide.
*Ransomware: A type of malware. In Ransomware, computers infected by this virus are restricted from browsing files such as documents on infected terminals, so the victim is required to pay the ransom to the malware author in order to release the restriction. It is a ransom request type malicious program.
MP-3 Press Release
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GYC-500 Press Release
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President and CEO, Mr. Motoki Ozawa stated, The Food and Drug Administration has completed an evaluation of our firm’s corrective actions in response to its Warning Letter dated August 8, 2014. Based on their evaluation, the FDA confirmed that Nidek Inc. has addressed the issues contained in the Warning Letter and resulted in full resolution of this matter.
NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved the use of the OPD-Scan III aberrometer and update the Final Fit software to facilitate compatibility with a new aberrometer to perform topography-assisted laser in-situ keratomileusis (LASIK)…..
We announced today that Nidek is cooperating fully with the Food and Drug Administration (FDA) to resolve the issues identified in the FDA’s August 2014 warning letter….
FREMONT, California, July 16, 2014
NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces that the United States Food & Drug Administration (FDA) has issued 510K clearance for it’s revolutionary new AL-Scan Optical Biometer that provides 6 essential values for cataract surgery very quickly. The auto tracking and auto shot capabilities make acquisition speedy and straightforward…..
FREMONT, California, March 19, 2014
NIDEK, Inc. a global leader in the design, manufacturing, and distribution of ophthalmic equipment, is pleased to announce FDA clearance of the RS-3000 Advance. This premier OCT system incorporating Scanning Laser Ophthalmoscope is designed for comprehensive evaluation of the retina and choroid. The RS-3000 Advance provides exquisite detail of the retinal and choroidal microstructures to assist in clinical diagnosis……
NIDEK, a global leader in diagnostic and laser instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has issued 510K Clearance for its revolutionary new CEM-530 Specular Microscope…..
NIDEK, a global leader in laser and diagnostic instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has approved its highly innovative Customized Aspheric Treatment Zone (CATz) for the NAVEX Quest; EC-5000 Excimer Laser System, one of the first topography-assisted LASIK procedure…..
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The latest ophthalmic lasers have features that allow more accurate targeting inside the eye, which is safer in the hands of the surgeon and translates to better recovery for patients. Your facility may even benefit from decreased procedure times, which could let you see more patients in a day or just give your staff and physicians a little breathing room to spend a little extra time with patients and their caregivers.
FREMONT, Calif. and JACKSONVILLE, Fla., May 15, 2012 ” NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces the FDA 510(k) Clearance for the AFC-330, their most automated fundus camera yet.
FREMONT, Calif. and JACKSONVILLE, Fla., February 27, 2012
NIDEK announces a market expansion of the their fundus camera distribution by granting MARCO Ophthalmic exclusive rights to sell NIDEK’s newest fundus camera to the optometry market. NIDEK Inc. will continue to provide sales and service to the Ophthalmology market, as well as service to their existing customers. NIDEK is currently pursuing FDA clearance for its newest fundus camera. Joint distribution of the product will begin once FDA clearance is obtained.