Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. specializes in home-use intense pulsed light (IPL) hair removal units designed for personal, at-home use. These devices are intended to help users reduce unwanted hair growth without professional intervention.

The company is based in the United States. This location may influence regulatory pathways and compliance requirements for its devices, though individual products must still meet applicable regulatory standards for authorization.

The company’s devices are classified as Class II medical devices. This classification typically indicates moderate risk, requiring compliance with specific regulatory controls to ensure safety and effectiveness before authorization.

The company’s devices are listed in the FDA 510(k) Premarket Notification registry and the FDA Unique Device Identifier (UDI) system. These registries track devices that have undergone the 510(k) clearance process, demonstrating they meet FDA requirements for safety and performance.

Inclusion in the FDA 510(k) registry means the devices have undergone a premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards. The UDI system assigns a unique identifier to each device to improve tracking, reduce medical errors, and enhance transparency in the supply chain. Both registries are part of the FDA’s efforts to monitor and regulate medical devices.