FDA Says Stop Using Unapproved Medical Devices

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Medical device maker, Sybaritic Inc., has agreed to stop making and distributing various medical products used in laser surgery, dermatology, and spa treatments until it meets U.S. Food and Drug Administration (FDA) quality standards. The unapproved devices lack appropriate FDA clearance review and safety and effectiveness approval. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.

“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 consent decree terms, Sybaritic must 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 certify to the FDA that appropriate corrections have been made.

The company 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 SVRH), ultrasound and non-invasive subdermal therapy systems (Dermosonic), and microdermabrasion systems (SkinBella).

The SkinBella was never 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 products that are not included in the agency’s clearances and constitute major changes or modifications in the devices’ intended use. Sybaritic has also made changes to some of these products’ designs that are not included in the clearances and that could significantly impact their safety and effectiveness.

FDA inspections conducted at Sybaritic over the past several years, and recently in March 2009, disclosed violations of the agency’s QS regulation, including transgressions related to design controls, complaint handling, corrective and preventive action, and quality audits. The scrutiny also revealed the company’s sale of numerous equipment that had not undergone the required FDA premarket review as well as the company’s failure to submit medical device reports to the agency as required.

The consent decree requires Sybaritic to obtain appropriate FDA approval or clearance before it distributes any devices. Once Sybaritic makes the corrections specified in the consent decree, an independent auditor must conduct yearly inspections of all its facilities for at least four years and report the results to the FDA.

If  future violations occur at Sybaritic, the consent decree allows FDA to order Sybaritic to stop manufacturing and distributing and to recall their products. FDA can take other actions to ensure Sybaritic is compliant with FDA regulations. It could assess damages of $15,000 a day if the company does not comply with any decree provisions and an additional $15,000 for each violation.

The FDA is not aware of any adverse events, but is advising consumers to discontinue using these products.

The consent decree was signed on Jan. 4, 2010, by U.S. District Court Judge John R. Tunheim of the U.S. District Court for the District of Minnesota.