The Food & Drug Administration shut down Sybaritic Inc., a Minnesota-based cosmetic device maker, until the company can bring itself back into compliance with FDA quality standards.
The federal watchdog agency, Sybaritic and three of its top officials inked a consent decree in the U.S. District Court for Minnesota barring the company from making its laser surgery, dermatology and spa treatments until it corrects the problems identified by the FDA. Those include marketing an unapproved device, marketing cleared devices but making unapproved claims about them and modifying devices in ways not covered by their clearances, according to court documents.