FDA WARNING_LETTER - Lucky Beauty Equipment Co., LTD.

The FDA issued a Warning Letter to Lucky Beauty Equipment Co., LTD for marketing several beauty devices in the U.S. without required marketing clearance or approval. The devices include the Panda-B RF Beauty Device, Lipolaser Machine, LBS11 RF Skin Lift, LBS54 Lipo Laser Fat Burner, LBS56 Lipolaser, and LBS12 Vertical RF.

The FDA reviewed the firm's website (www.luckybeauty.net) and found these devices are marketed with various indications, such as face lifting, fat removal, cellulite reduction, skin tightening, and wrinkle removal. These indications classify the products as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The devices are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to commercially distribute the devices, as required by section 510(k).

The FDA requests the firm immediately cease activities resulting in the misbranding or adulteration of these devices. The devices are subject to refusal of admission into the U.S. under section 801(a) of the Act, leading to "detention