1.8.10 | MassDevice Staff

FDA shuts down Minnesota’s Sybaritic

The Food & Drug Administration shut down Sybaritic Inc., a Minnesota-based cosmetic device maker, until the company can bring itself back into compliance with FDA quality standards.

The federal watchdog agency, Sybaritic and three of its top officials inked a consent decree in the U.S. District Court for Minnesota barring the company from making its laser surgery, dermatology and spa treatments until it corrects the problems identified by the FDA. Those include marketing an unapproved device, marketing cleared devices but making unapproved claims about them and modifying devices in ways not covered by their clearances, according to court documents.

The FDA said its case against Sybaritic, CEO Anthony Daffer, chairman and owner Steven Daffer and product manager Ronald Berglund involves the company’s Dermalife moist steam cabinets called the Hydration Station, Spa Oceana, Spa Jet and Spa Fengshui; its NannoLight MP50, LaserPeel Trimatrixx and SkinClear SRVH laser systems; its Dermosonic ultrasound and non-invasive subdermal therapy systems; and its SkinBella microdermabrasion systems.

“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,” according to an FDA press release. “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 revealed those violations and violations of the QS standards related to design controls, complaint handling, corrective and preventive action, and quality audits. The inspections also turned up reporting lapses by the company.

Sybaritic must now win FDA clearance before it can resume sales of any of its devices; future violations after sales resume could trigger another injunction, recall of the offending devices and fines of $15,000 a day plus a $15,000 penaly for each violation, according to the agency.

“The FDA is not aware of any adverse events, but is advising consumers to discontinue using these products,” according to the press release.

MassDevice Staff

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Tags: medical devices, Minneapolis, Minnesota, Northeast Ohio, Sybaritic, U.S. Food and Drug Administration

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SYBARITIC AGREES WITH FDA TO SUSPEND US MEDICAL DEVICE SALES WHILE IT CONTINUES INTERNATIONAL SALES AND MANUFACTURING

Sybaritic has signed a consent decree with the FDA to suspend selling its medical devices in the US while it works to improve its quality system processes and modify some of its claims. Sybaritic has worked cooperatively with the FDA in the past and has obtained FDA 510(k) clearances to market its medical products. Sybaritic, Inc. does not agree with the allegations in the FDA Complaint, but is cooperating with the FDA to resolve the issues raised.

Sybaritic firmly stands behind the quality of all of its products, and is dedicated to promptly resolving its record-keeping and improving its quality system documentation and processes. The FDA has acknowledged it is not aware of any adverse events concerning Sybaritic’s products. FDA attorney Bob Klepinski of Fredrikson & Byron, who represents Sybaritic and its management team, Steven J. Daffer, Anthony S. Daffer and Ronald Berglund, is optimistic that once the FDA conducts a full and fair review of its processes, the FDA’s concerns will be satisfied and that Sybaritic soon will be able to resume its U.S. sales of medical devices.

All manufacturing of exports and international sales of Sybaritic’s products–including all medical devices, spa capsules, beauty and cosmetic products–will continue unaffected by the consent decree. Sybaritic will also continue its U.S. sales of beauty, cosmetic & non-medical products.

Sybaritic is a recognized worldwide pioneer, distributor and a national leader in beauty and spa products. Sybaritic is the original inventor and world’s number one seller of premium quality spa capsules, including the Dermalife, with a world network of suppliers and distributors and a proven safety record.

Any further questions should be directed to Sybaritic’s attorneys, Bob Klepinski (rklepinski@fredlaw.com) or Dulce Foster (dfoster@fredlaw.com).

Comment by SYBARITIC — January 8, 2010 @ 11:18 pm

SYBARITIC CONTINUES INTERNATIONAL SALES AND MANUFACTURING

Comment by SYBARITIC — January 8, 2010 @ 11:20 pm

[...] week, the FDA barred the company from making its laser surgery, dermatology and spa treatments until it corrects a host ofÂ problems,Â including marketing an unapproved device, marketing [...]

Comment by Minnesota’s Sybaritic agrees to suspend U.S. sales of medical devices in wake of FDA shutdown : MedCity News — January 11, 2010 @ 9:52 am