Shenzhen Weikai Technology Co., Ltd

Shenzhen Weikai Technology Co., Ltd specializes in cosmetic red-light phototherapy systems designed for home use. Their most common product category is IPL (intense pulsed light) hair removal devices, which use controlled light pulses to target hair follicles for reduction or removal.

The company is based in the United States. While the name suggests a location in Shenzhen (China), the operational headquarters or primary manufacturing presence for regulatory purposes is in the US.

The devices manufactured by Shenzhen Weikai Technology Co., Ltd fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as IPL hair removal systems.

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 track devices that have undergone the required regulatory pathways (e.g., 510(k) clearance) and are assigned unique identifiers for traceability.

The FDA categorizes IPL hair removal devices as Class II because they involve controlled energy delivery to the skin, which carries a moderate risk of adverse effects (e.g., burns, pigmentation changes) if misused. Class II classification requires compliance with special controls, such as performance standards and post-market surveillance, to mitigate risks while allowing broader availability compared to higher-risk Class III devices.