Dongguan Define Beauty Electronic Technology Co., Ltd.

The company specializes in home-use intense pulsed light (IPL) devices, specifically designed for hair removal. These are standalone units intended for consumer use at home, such as the Define Beauty and IPL Hair Removal systems.

The company is based in the United States. This location is relevant for regulatory compliance and market distribution, particularly for devices intended for the US market.

The devices produced by the company fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness beyond general controls.

The company’s devices are listed in the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identifier (UDI) system. These registries help track device performance, compliance, and market availability under US regulatory requirements.

The FDA’s UDI system assigns a unique product identifier to medical devices to improve tracking, reduce medical errors, and enhance the efficiency of device recalls or safety alerts. Since the company’s IPL hair removal devices are marketed in the US, they must comply with UDI requirements to ensure traceability and regulatory transparency.