Shenzhen Jianchao Intelligent Technology Co., Ltd.

Shenzhen Jianchao Intelligent Technology Co., Ltd. specializes in home-use intense pulsed light (IPL) devices, with a focus on hair removal. Their most common product category is the IPL hair removal unit, including models like the JIANCHAO SMART series and variants such as the R3C16-P Pro or R3505-B Pro. They also produce facial and body beauty devices, such as the INIA-BD001 series, which are designed for skin treatments and additional hair removal applications. These devices are intended for consumer use in personal grooming and aesthetic care.

Shenzhen Jianchao Intelligent Technology Co., Ltd. has a presence in the United States, though its headquarters are located in Shenzhen, China. Their devices are regulated as Class II medical devices in the U.S., and they comply with pathways like the FDA’s 510(k) pre-market notification process and Unique Device Identification (UDI) requirements. Their products are listed in the FDA’s regulatory databases, including the 510(k) and UDI registries, ensuring traceability and compliance with U.S. medical device regulations.

Shenzhen Jianchao Intelligent Technology Co., Ltd.’s devices are listed in the FDA’s regulatory registries, specifically the 510(k) database and the Unique Device Identification (UDI) system. These registries track Class II medical devices that have undergone the required regulatory pathways, such as the 510(k) pre-market submission process, to ensure compliance with U.S. medical device regulations before they enter the market.

Shenzhen Jianchao Intelligent Technology Co., Ltd.’s devices are classified as Class II medical devices under U.S. regulations. This classification applies to products that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness. Class II devices typically require pre-market submissions like the 510(k) pathway to demonstrate substantial equivalence to a legally marketed predicate device.