FDA Refusing Imports of Beauty Devices From Chinese Company
The Food and Drug Administration said it is taking steps to refuse entry to several devices made by Lucky Beauty Equipment Co., Ltd. in China, because the company is marketing them in the U.S. for unapproved uses. According to FDA’s…
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Jan. 15 warning letter, Lucky Beauty markets in the U.S. its Panda-B RF Beauty Device, the Lipolaser Machine, the LBS11 RF Skin Lift, the LBS54 Lipo Laser Fat Burner, the LBS56 Lipolaser, and LBS12 Vertical RF. The company’s website lists uses including cellulite removal, face lifting, removing wrinkles, removal of fat, and body shaping as uses for the various devices. Because these uses would affect the structure or function of the body, FDA considers the products to be medical devices that require approval, which Lucky Beauty hasn’t obtained. FDA said it will detain the devices at the border without physical examination until the violations are corrected.