Yetsea Medical Secures Class II Certification for China's First Ultra-Widefield Scanning Laser Ophthalmoscope

Recently, Yesight, a company within Medpark, has received the Class II medical device registration certificate for its first ultra-widefield laser scanning ophthalmoscope. This signifies that the high-end ultra-widefield fundus laser imaging category is set to embrace a new transformation.

Yesight's Scanning Laser Ophthalmoscope (SLO), as one of the first SLO devices in China to complete clinical trials, has gained clinical recognition from top ophthalmic hospitals in China, including Beijing Tongren Hospital, Shenzhen People's Hospital, and Guangzhou Aier Eye Hospital. Its performance indicators have reached or even surpassed the standards of imported products, providing comprehensive and clear imaging of fundus changes. It offers precise diagnostic support for doctors, aiding in the early detection of blinding eye diseases and continuous monitoring of conditions, thereby optimizing the diagnostic process and significantly improving clinical detection rates. Its non-contact design combined with a safe laser light source ensures a low-risk, comfortable, and harmless examination process, enhancing patient experience. This highlights China’s medical technology innovation capabilities and leads the innovation in the field of ophthalmic medical devices.

As an ultra-wide-angle SLO device, this product achieves a single-shot imaging range of 168°, featuring wide-field fundus imaging, no need for pupil dilation, strong penetration through refractive media, fast imaging speed, and clear images, providing unprecedented convenience and accuracy for fundus examination.

It is worth mentioning that this device adopts the four-wavelength laser (R/G/B/IR) stratified scanning imaging technology. By utilizing the scanning depth differences of lasers with different wavelengths, it can fully cover the diagnostic areas of the 10-layer tissue structure of the retina at the bottom of the eye, providing doctors with broader, more comprehensive, and deeper clinical information about the eye.

Schematic Diagram of Four-Wavelength Laser Stratified Scanning

This device, developed by Yesight, is the world's first ultra-widefield confocal laser scanning ophthalmoscope based on electronic scanning mirror technology. Technologically, it achieves a more compact design while offering enhanced performance scalability. The core components are self-developed, supported by multiple patented technologies and intellectual property rights, setting a new precedent in the SLO imaging field. The product’s portability allows flexible deployment to remote or inaccessible areas, significantly expanding the reach of medical services. It brings advanced ophthalmic diagnostic capabilities to grassroots medical institutions, meeting the needs of local patients for high-quality eye examinations and providing an innovative and efficient solution for eye health services.

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Mr. Haizhou Wu, founder of Yesight, said confidently:

"This Scanning Laser Ophthalmoscope (SLO), with its compact design, embodies the years of research and hard work by our team. Its successful approval not only affirms our efforts but also marks an important milestone for Yesight as we officially enter the high-end ultra-widefield SLO market in China. We are deeply proud to provide Chinese ophthalmologists with more efficient and precise diagnostic tools through our self-innovated Chinese technology, working together to protect patients' eye health."

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In the future, Yesight is committed to comprehensively covering multiple ophthalmology specialty fields such as fundus, anterior segment, optic nerve, and optometry, striving to meet over 90% of ophthalmic diagnostic needs in China. Yesight will continue its research, development, and innovation, enhancing cutting-edge technologies like automation and AI, with the aim of launching advanced, self-developed ophthalmic medical devices. This effort seeks to make a more significant contribution to the advancement of China's ophthalmology healthcare sector and the ocular health of the public. Meanwhile, actively embracing globalization trends, the company is expanding into overseas markets and strengthening cooperation and exchange with internationally renowned medical institutions, aiming to provide more precise and efficient diagnostic and treatment services for ophthalmic patients worldwide.

About Yesight

About Medpark

Jiangsu Medical Device Science and Technology Industrial Park Medpark is a national-level medical device science and technology industrial park jointly built by Suzhou New District and the Suzhou Institute of Biomedical Engineering Technology of the Chinese Academy of Sciences. The operating entity is Suzhou Medical Device Industry Development Group Co., Ltd., which is responsible for coordinating the resources of Suzhou New District, relying on three core capabilities: "carrier development and construction + park operation + industrial investment," focusing on the development of the medical device industry. The industrial park has successively been approved as a national torch plan medical device characteristic industrial base, a national innovative medical device industry cluster pilot, a national-level medical device professional incubator, and a national-level science and technology entrepreneurship incubation chain construction demonstration unit, among other national honorary titles.