FDA to Refuse Entry of Cavi-Lipo Devices From South Korean Manufacturer
The Food and Drug Administration will refuse entry of Cavi-Lipo devices from South Korean device manufacturer SkinRex because it is being marketed for unapproved uses, said the Food and Drug Administration in a warning letter dated Dec. 12. Although electric…
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therapeutic massagers are exempt from premarket notification, SkinRex is marketing its Cavi-Lipo device for use in the treatment of cellulite, and compares the treatment to liposuction in its marketing materials. As such, the device needs premarket approval from FDA, which SkinRex did not obtain, said the agency. FDA said it is “taking steps to refuse entry of these devices in the United States” through detention without physical examination.