Navigation Links
FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
Date:1/8/2010

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. 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 the Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

"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 SRVH), 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.

FDA's Web site on Laser Facts:

http://www.fda.gov/Radiation-EmittingProducts/ResourcesforYouRadiationEmittingProducts/Consumers/ucm142607.htm

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

RELATED LINKS
http://www.fda.gov/

'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Effective Pain Management Requires an Interdisciplinary Approach
2. American Medical Womens Association Supports New Bill That Requires Medicare Coverage of HPV Testing as Part of Cervical Cancer Screening
3. Vermont Requires Reporting of NQF Serious Reportable Events
4. Justice Department Requires Divestitures in Pearsons Acquisition of Harcourt Assessment
5. Growing Importance of March 4 Texas Primary Requires 2008 Presidential Candidates to Better Address Eldercare Financing Issues
6. Aetna Requires CAQH Core Rules Certification for Vendors
7. Justice Department Requires Divestiture in UnitedHealth Groups Acquisition of Sierra Health Services
8. Study finds that competency in colonoscopy requires experience with 150 cases or more
9. Improving Access to Safe Water, Sanitation, Hygiene Requires Better Decision-Making Tools, Finds Joint Wilson Center-Pacific Institute Report
10. TB treatment for the elderly likely requires a boost to immune response
11. Solving California Nursing Shortage Requires Redesigned Education System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... CHAPEL HILL, N.C. , June 24, 2016 ... in healthcare decisions and regulators/payers have placed more ... this new environment, patient support programs in the ... support for patients, medications. Consequently, pharmaceutical companies are ... to ensure they are providing products and services ...
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
Breaking Medicine Technology: