Minn. Medical Device Maker Agrees to Shut Down

Medical device manufacturer Sybaritic Inc. has agreed to stop making products used in laser surgery, spa treatment, and dermatology procedures until the company complies with Food and Drug Administration safety regulations, officials said.

The Bloomington, Minn. company and the FDA entered into a consent decree involving company products which are considered to be unapproved medical devices since they do not have appropriate FDA clearance review and approval for safety and effectiveness. 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, FDA officials said.

“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.”

Injuries From Defective Medical Devices

Each year, defectively dangerous medical devices account for thousands of patient deaths and injuries. Pacemakers and defibrillators that fail to work properly and other types of defective medical devices can result in fatal or life-threatening injuries in users.

Sybaritic agreed to comply with the FDA’s Quality System regulation for all of its devices. The company also agreed to retain an independent expert consultant to inspect its operations and to certify to the FDA that corrections have been made.

Various Products Involved

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 FDA said.

The SkinBella system has never been approved or cleared by the FDA, officials said.  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 also has made changes to some of these devices’ designs that are not included in the clearances and which could significantly impact their safety and effectiveness, the FDA said.

The company could face 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, according to the FDA.

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