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.
The FDA said its case against Sybaritic, CEO Anthony Daffer, chairman and owner Steven Daffer and product manager Ronald Berglund involves the company’s Dermalife moist steam cabinets called the Hydration Station, Spa Oceana, Spa Jet and Spa Fengshui; its NannoLight MP50, LaserPeel Trimatrixx and SkinClear SRVH laser systems; its Dermosonic ultrasound and non-invasive subdermal therapy systems; and its SkinBella microdermabrasion systems.
“The SkinBella has never been approved or cleared by the FDA. The Dermalife, NannoLight MP50, SkinClear SRVH, and the Dermosonic devices are unapproved because, although the devices have FDA clearance for marketing, Sybaritic has made claims for these devices that are not included in the FDA clearances and constitute major changes or modifications in the devices’ intended use,” according to an FDA press release. “Sybaritic has also made subsequent changes to some of these devices’ designs that are not included in the clearances and that could significantly impact their safety and effectiveness.”
FDA inspections revealed those violations and violations of the QS standards related to design controls, complaint handling, corrective and preventive action, and quality audits. The inspections also turned up reporting lapses by the company.
Sybaritic stressed that it does not agree with allegations made by the U.S. Food and Drug Administration, but it is cooperating with the agency in an attempt to resolve issues raised in the FDA’s complaint, according to a statement posted on MassDevice.
Sybaritic must now win FDA clearance before it can resume sales of any of its devices; future violations after sales resume could trigger another injunction, recall of the offending devices and fines of $15,000 a day plus a $15,000 penaly for each violation, according to the agency.
“The FDA is not aware of any adverse events, but is advising consumers to discontinue using these products,” according to the press release.