Sybaritic Agrees to Stop Manufacturing Some Medical Products After FDA Agreement

Medical device maker Sybaritic Inc. has agreed to stop producing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with U.S. Food and Drug Administration (FDA) quality standards, according to the agency.

A statement by the FDA said these products have not been approved by the agency, and the Silver Spring, Md., company and three of its executives, Anthony Daffer, Steven Daffer and Ronald Berglund, have signed an agreement.

“This action halts the manufacture of these products until the manufacturer comes into compliance with federal law,” said Jeffrey Shuren, M.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 agreement, Sybaritic has agreed to comply with the FDA’s quality system regulations 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, according to the FDA.

The firm designs, manufactures and distributes a variety of medical devices including moist steam cabinets,laser systems, ultrasound and non-invasive

subdermal therapy systems and microdermabrasion systems.