The company noted that it has been selling the GalvanicSpa facial unit for 10 years in the U.S. as a cosmetic appliance, and that the product has a solid safety record.
Recently, in connection with a review of in-bound shipments of the GalvanicSpa facial unit, the U.S. Food and Drug Administration (FDA) indicated its belief that the product needed to be registered as a medical device before being imported.