Kernel Medical expands international market and gets "VIP pass"

Internationally recognized industry benchmark

In June 2020, the new ultraviolet light therapy device series represented by "DC, prescription" and high-energy pulse laser hair generator series products of Kernel Medical successfully passed the US FDA and EU CE certification, and the company added an international "green pass" ，This is also a embodiment of Kernel's "facing the world" strategy and another milestone in achieving global deployment.

The successful CE certification has extended the CE certification model of Kernel ultraviolet light therapy instrument to nearly 50 models, including NB-UVB series and 308nm excimer series, covering medical and household ultraviolet light therapy instruments, prescription、classic two working methods, Two forms of power supply, DC and AC; suitable for various treatment scenarios such as hospitals, clinics and homes.

At the same time, CE certification, product safety performance meets "EN60601-1-11 requirements for medical electrical equipment and medical electrical systems used in home health care environment" and "IP22 waterproof and dustproof grade，dripping and solid waste will not cause harmful effects to Instruments ." The main technical indicators of the product (wavelength, intensity, software operation, etc.) all meet the standard requirements.

The FDA (United States Food and Drug Administration) has been certified by the World Health Organization as the highest safety standard and is a passport to enter the US market. KN-4003 is the first ultraviolet phototherapy instrument to obtain FDA certification in China. Since then, FDA officials have repeatedly conducted on-site audits at the headquarters of Kernel Company, and highly praised Kernel Medical's product performance and safety.

The KN-8000 laser hair generator series is an “explosive” product that “fits to the needs and tendency from ”. With the acceleration of life rhythm and the increase of work pressure, the phenomenon of alopecia is becoming more and more common, and the trend of youth is becoming more and more serious. Therefore, a laser hair generator that meets the medical technology standards and meets the safety performance of the home is born. Effective and satisfy various treatment environments!

As verified by FDA, the safety performance of KN-8000 laser hair generator conforms to "IEC 60601-1-11 medical electrical equipment. Part 1-11: General requirements for basic safety and necessary performance. Auxiliary standard: medical electrical equipment for home health And medical electrical system requirements" and "IP22 waterproof and dustproof grade-dripping water and solid waste will not cause harmful effects to the instrument." The main technical indicators of the product (effective irradiation area, laser radiation power, software operation, etc.) all meet the standard requirements.