Minnesota’s Sybaritic agrees to suspend U.S. sales of medical devices in wake of FDA shutdown

Sybaritic stressed that it does not agree with FDA allegations that it marketed an unapproved device and made claims not covered by FDA clearances, but the company says it is cooperating with the agency.

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BLOOMINGTON, Minnesota — Embattled cosmetic device maker Sybaritic Inc. has agreed to stop selling medical devices in the U.S. after the Food and Drug Administration ordered it to bring itself into compliance with quality standards.

Sybaritic stressed that it does not agree with allegations made by the FDA, but it is cooperating with the agency in an attempt to resolve issues raised in the FDA’s complaint, according to a statement from the company.

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Last week, the FDA barred the company from making its laser surgery, dermatology and spa treatments until it corrects a host of  problems, including marketing an unapproved device, marketing cleared devices but making unapproved claims about them and modifying devices in ways not covered by clearances.

Sybaritic said it would continue U.S. sales of beauty, cosmetic and non-medical products and international sales of all its products while it works with the FDA.

The FDA’s case 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 noninvasive 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,” the FDA said last week. “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.”

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 penalty for each violation, according to the agency.