Miley Technology (Hebei) Co., Ltd.

Miley Technology (Hebei) Co., Ltd. specializes in home-use intense pulsed light (IPL) devices primarily for hair removal. These devices emit controlled light pulses to target and reduce unwanted hair growth, making them suitable for consumer use in a home setting. The company’s portfolio includes standalone IPL units like the Iouniya and louniya, as well as multiple model variants such as the MLY-T069 and the MLY-M011 series.

Miley Technology (Hebei) Co., Ltd. is based in the United States. The company’s location is relevant for understanding its regulatory oversight and compliance context, particularly for devices marketed in the US market.

The devices produced by Miley Technology (Hebei) Co., Ltd. are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries help track and identify devices that have undergone the necessary regulatory pathways, such as 510(k) clearance, to ensure compliance with US medical device regulations.

The devices manufactured by Miley Technology (Hebei) Co., Ltd., including their IPL hair removal units, are classified as Class II under regulatory frameworks. This classification typically indicates moderate risk and requires compliance with specific controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness before they are authorized for market distribution.