March 11, 2025
Source: drugdu
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Recently, the Jiangsu Provincial Medical Products Administration released the "Announcement of the Examination Results of Priority Approval Applications for Class II Medical Devices (No. 3 of 2025)", intending to approve the priority registration process for the ultraviolet phototherapy device of Xuzhou Kono Medical Instrument Equipment Co., Ltd. (hereinafter referred to as "Kono Medical").
Heavy equipment, registration process accelerates
Ultraviolet radiation is an invisible light with a wavelength between 100-400nm, which can be divided into UVC radiation (100-280nm), UVB radiation (280-320nm), and UVA radiation (320-400nm). Ultraviolet radiation has sufficient energy to destroy the DNA structure of microorganisms, thus effectively inhibiting the activity of viruses and bacteria.
Research has shown that ultraviolet radiation has the effects of accelerating blood circulation, relieving pain, and promoting epithelial regeneration, making it effective in treating diseases such as herpes, psoriasis, and atopic dermatitis. In addition, ultraviolet radiation also promotes the production of vitamin D, which can effectively promote the absorption of calcium and have an important impact on bone health.
Ultraviolet phototherapy device is a type of medical equipment developed using the relevant functions of ultraviolet radiation, which has auxiliary therapeutic effects on various skin diseases. The ultraviolet phototherapy device, which is planned to be included in the priority approval by the Jiangsu Provincial Medical Products Administration, is a second-class medical device developed by Kono Medical, including two specifications and models: KN-5000A and KN-5000B. According to the public announcement, the product meets the requirements specified in Article 4, Item (4) of the "Jiangsu Province Second Class Medical Device Priority Registration Procedure (Trial)".
It is reported that in addition to the UV phototherapy device planned to be included in the priority approval by the Jiangsu Provincial Drug Administration, there are also multiple products of the same series on Kono Medical's product pipeline, including medical UVAUVB UV phototherapy device, medical 308nm, medical UVA1, household UV phototherapy device (308/311/UVA1), etc.
According to the official website, products of different categories use different wavelengths and have different effects. For example, NB-UVB ultraviolet radiation with a wavelength of 311nm is mostly absorbed by dermal tissue, thus having a significant biological regulatory effect on the subcutaneous microenvironment; The 308nm ultraviolet phototherapy device uses xenon chloride excimer light source, which can emit high-intensity 308nm ultraviolet light, highlighting the rake like nature of treatment, with fewer adverse reactions, and can efficiently remove lesions
After the UV phototherapy device from Kono Medical is included in the priority approval, it is expected to further accelerate the registration process and become one of the company's flagship products.
Innovation driven, accelerating technological breakthroughs
Kono Medical is engaged in the research and production of medical devices in the field of skin beauty, and regards innovation as the core driving force for development. According to reports, in recent years, Kono Medical's R&D investment has accounted for more than 10% of its annual revenue, and the proportion of R&D personnel is as high as 40%. At present, Kono Medical has launched a series of heavyweight medical equipment.
In vivo reflection confocal microscope
In vivo reflection confocal microscope is China's first skin CT with independent intellectual property rights, successfully breaking the technological monopoly of imported equipment. In clinical practice, this product has been used to collect, store, retrieve, display, and convert in vivo images of unstained epithelial cells and tissues on the body surface, assisting doctors in clinical diagnosis. According to the official website of Kono Medical, in vivo reflective confocal microscopy uses 830nm near-infrared laser to compress the three-dimensional cellular world into two-dimensional images, transforming complex pathology into a quantifiable data plane.
LLLT semiconductor laser generator
The LLLT semiconductor laser generator uses a low-energy laser (LLLT) with a wavelength of 670nm, also known as a soft laser. Research has shown that LLLT laser can emit coherent light for precise wavelength control and high focusing, and penetrate the skin to promote tissue repair and regeneration. Kono Medical's LLLT semiconductor laser hair generator utilizes this principle to promote hair growth by irradiating the head.
Green/Red/Blue/Yellow/Infrared Five Light Source LED Spectral Therapy Device
The green/red/blue/yellow/infrared five light source LED spectrometer uses the non photothermal effect of LED solid-state cold light source to regulate cell activity and achieve related functions. It is understood that each of these types of light sources plays an important role. Among them, red, blue, yellow, and green light belong to cold light and do not produce high fever. Green light has the effects of calming the skin, balancing skin tone, softening keratin, promoting skin metabolism, and improving roughness and dullness; Red/yellow/blue light can be used for the treatment of inflammatory acne. In addition, yellow and infrared light can be used to promote wound healing and alleviate wound pain. This device can achieve skin beauty and treatment of various skin diseases through the individual use of light sources or sequential combination of multiple light sources.
In addition, there are multiple high-end medical devices on the Kono medical pipeline, covering fields such as skin beauty, gynecology, rehabilitation, otolaryngology, ophthalmology, and emergency care. Kono Medical has stated in previous reports that it will continue to tackle production process challenges in more specialized fields and assist in the mass production of high-tech and high value-added products.
In the future, by accelerating innovation breakthroughs in key technologies of high-end equipment, Kono Medical is expected to further expand its product pipeline and achieve transformation and upgrading.
Conclusion
The successful inclusion of Kono Medical's ultraviolet phototherapy device in priority approval is expected to further accelerate the registration process of the product and help the enterprise seize and expand relevant market share.
Source: https://news.yaozh.com/archive/45113.html
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