Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. specialises in home-use intense pulsed light (IPL) devices primarily for hair removal. These devices are designed for consumer use and deliver controlled light pulses to target unwanted hair. The company’s portfolio includes standalone IPL units, such as the Nood and the IPL Hair Removal Device (Model: KCA423).

The company has a presence in the United States, where it operates in compliance with regulatory requirements for its medical devices. While the company’s headquarters are located in Shenzhen, China, its US operations likely handle regulatory submissions and market access for its authorised devices.

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries reflect the pathways used to authorise its Class II IPL hair removal devices, ensuring traceability and compliance with US medical device regulations.

The company’s IPL hair removal devices fall under Class II classification in the FDA’s regulatory framework. This classification is assigned based on the device’s intended use, risk profile, and the need for special controls to ensure safety and effectiveness. Class II devices typically require premarket submissions like the 510(k) pathway to demonstrate compliance with applicable regulations.