Spa and Beauty Devices Banned From United States
Potentially dangerous products not cleared for safety and effectiveness by the Food and Drug Administration's (FDA) have been removed from the market until they are in compliance with federal regulations.
All are products made by Sybaritic Inc., a major player in the development of beauty and spa products used in laser surgery and dermatology and spa treatments.
One product promises skin that is "soft, supple and youthful." Another, a laser therapy device, zaps unsightly veins, scars and unwanted hair. Another, a hydrospa tub, is advertised to provide the "ultimate luxury."
But according to the FDA, these devices were not approved by the FDA and lack the proper federal review for safety and effectiveness. In response to the FDA action, Sybaritic has agreed to stop making the products in the United States until they are in compliance with FDA quality standards.
The agreement with the FDA is part of a consent decree reached between the U.S. Department of Justice, which filed for an injunction late last year, and three of Sybaritic's top executives.
Sybaritic agreed to comply with FDA quality regulations for all of its devices and obtain appropriate agency clearance before selling or distributing any of its products. The company must also retain an independent expert to inspect its operations and to certify to the FDA that appropriate corrections have been made.
If the company fails to follow the consent decree, the FDA could order it to cease manufacturing and distributing the products and then could recall them. The company could also face damages of $15,000 a day and an additional $15,000 for each violation.
Some of the products cited by the FDA include moist steam cabinets or tubs (under names such as Hydration Station, Spa Oceana, Spa Jet and Spa Fengshui), laser systems (NannoLight MP50, LaserPeel Trimatrixx and SkinClear SVRH), ultrasound and non-invasive skin therapy systems (Dermosonic), and microdermabrasion systems (SkinBella).
Although the FDA said it is not aware of any injuries associated with the use of Sybaritic products, it still advises consumers to stop using them.
