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 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 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 SVRH), ultrasound and non-invasive subdermal therapy systems (Dermosonic), and microdermabrasion systems (SkinBella).
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. 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 conducted at Sybaritic over the past several years, and most recently in March 2009, revealed violations of the agency’s QS regulation, including violations related to design controls, complaint handling, corrective and preventive action, and quality audits. These inspections also revealed the company’s sale of numerous devices 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 may distribute any of its devices. Once Sybaritic makes the corrective actions specified in the consent decree, it must hire an independent auditor to conduct annual inspections of all its facilities for at least four years and report the results to the FDA.
In the event of future violations at Sybaritic, the consent decree allows FDA to order Sybaritic to cease manufacturing and distributing products and to recall them. FDA can take other actions to ensure Sybaritic is compliant with FDA regulations. The company may be required to pay damages of $15,000 a day if it fails to comply with any provisions of the decree 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.
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