SKINREX CO., LTD – FDA Warning Letter

The FDA issued a Warning Letter to SkinRex Co., Ltd. for marketing their Cavi-Lipo device in the U.S. without proper marketing clearance or approval. The Cavi-Lipo is deemed a device under section 201(h) of the Act.

The device is adulterated under section 501(f)(1)(B) because SkinRex lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) as it was introduced into interstate commerce for a use different from a legally marketed device (Electric Therapeutic Massager, 21 CFR 890.5660) without a 510(k) premarket notification.

While Electric Therapeutic Massagers are generally exempt from premarket notification, the Cavi-Lipo's intended use for temporary reduction in the appearance of cellulite, dissolving adipose tissue, and discharging wastes, and claims comparing results to liposuction, exceed the exemption limitations (21 CFR 890.9(a)). The FDA considers Cavi-Lipo an ultrasound diathermy device, subject to premarket approval under 21 CFR 890.5300(b) for its marketed uses.

SkinRex Co., Ltd. is required to immediately cease activities resulting in the misbranding or adulteration of the Cavi-Lipo. Due to