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FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
Date:1/8/2010

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by the Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.

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"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. "It's critical that companies comply with laws that are in place to protect consumer health."

Under the terms of the consent decree, Sybaritic agrees to comply with the FDA's Quality System (QS) regulation for all of its devices. Sybaritic also must retain an independent expert consultant to inspect its operations and to certify to the FDA that corrections have been made.

Sybaritic designs, manufactures and distributes a variety of medical devices including moist steam cabinets (Dermalife products such as Hydration Station, Spa Oceana, Spa Jet, and Spa Fengshui), laser systems (NannoLight MP50, LaserPeel Trimatrixx, SkinClear SRVH), ultrasound and non-invasive subdermal therapy systems (Dermosonic), and microdermabrasion systems (SkinBella).

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SOURCE U.S. Food and Drug Administration
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