The U.S. Food and Drug Administration has announced that Sybaritic Inc., has signed a consent decree to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until the company is in compliance with FDA quality standards. Sybaritic, Inc. has U.S. offices in Bloomington, MN. The company and three executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund, signed the consent decree of injunction.

Sybaritic designs, manufactures and distributes several medical devices including moist steam cabinets (Dermalife products), laser systems (NannoLight MP50, LaserPeel Trimatrixx, SkinClear SVRH), ultrasound and non-invasive subdermal therapy systems (Dermosonic), and microdermabrasion systems (SkinBella).

"This action halts the manufacture of these products until the manufacturer comes into compliance with federal law," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health, in an FDA press release. "It's critical that companies comply with laws that are in place to protect consumer health."

According to the consent decree, Sybaritic is enjoined from importing, designing, or distributing devices in the U.S. until it is in compliance with Quality System regulation for all of its devices. The company must also retain an independent expert to conduct inspections of the operations and certify compliance.

The decree also requires Sybaritic to obtain FDA approval for designing, manufacturing or distributing any device. In addition, the company must obtain an independent auditor for inspections of operations at least every six months for one year and yearly thereafter for three years, with the results of the inspections being reported to the FDA.

According to the original FDA complaint in U.S. District Court, District of Minnesota, the FDA inspected Sybaritic early in 2009, and the inspections revealed numerous violations including distribution of adulterated and misbranded devices. The complaint says the company does not have an approved application for PMA or cleared 510(k) for their microdermabrasion system, SkinBella. In addition, although the Dermalife, NannoLight MP50, SkinClear SRVH, and the Dermosonic have FDA clearance for marketing, the complaint states that Sybaritic has made claims for these devices that are not included in the FDA clearances and are major changes or modifications in the devices' intended use.

If any future violations occur at Sybaritic, the consent decree allows FDA to order Sybaritic to cease manufacturing and distributing products and to recall them. In addition, the FDA can take other actions to ensure Sybaritic is compliant with FDA regulations.

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