Zhongshan Qizhe Technology Co., Ltd. is a company focused on the research, development, production, and sales of beauty and personal care devices. Today, the two IPL (Intense Pulsed Light) hair removal device models, Skin Expert Pro IPL008 and Skin Expert Pro IPL008S, have not only obtained the U.S. FDA 510(k) clearance but also acquired the medical device production license and the registration certificate for intense pulsed light therapy devices in China.
The acquisition of these certifications signifies that the hair removal devices of Qizhe Technology have gained international and domestic recognition for their safety and efficacy. The FDA 510(k) clearance is a premarket notification process conducted by the U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of medical devices. This certification process took one year, during which the devices underwent various tests, including biocompatibility testing, IEC62133, IEC60601, and IEC62471, conducted by the German testing agency, DEKRA.
Furthermore, according to the regulations set by the China's National Medical Products Administration (NMPA), intense pulsed light hair removal devices have been classified as Class II medical devices since 2022. Therefore, IPL hair removal device manufacturers and sellers in China must obtain the medical device production license and the registration certificate for intense pulsed light therapy devices issued by the NMPA in order to produce and sell such products within the country. After testing and review by the Guangdong Provincial Drug Administration, the two hair removal devices of Zhongshan Qizhe Technology Co., Ltd. successfully obtained the relevant medical device qualifications in October 2023.
Zhongshan Qizhe Technology Co., Ltd. has always been committed to providing its customers with products that comply with legal and regulatory requirements, and are genuinely effective. During the product design and development process, our R&D team has fully considered user needs and safety, and has adopted advanced technologies and materials to ensure the quality and performance of the products. Additionally, we have established a comprehensive quality management system to monitor the production, sales, and after-sales service of our products, ensuring their safety and efficacy.
The acquisition of the FDA 510(k) clearance, the medical device production license, and the registration certificate for intense pulsed light therapy devices are important milestones for Zhongshan Qizhe Technology Co., Ltd. in the fields of beauty and personal care, as well as medical devices. This not only proves the company's technical capabilities and product quality but also provides strong support for its further expansion into the international and domestic markets.
