| Subject: | FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices |
| Category: | Food and Drug Administration (FDA)
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| Published: | Mon, 11 Jan 2010 - 11:00 am |
| 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 devices include moist steam cabinets (Dermalife products such as Hydration Station, Spa Oceana, Spa Jet, and Spa Fengshui), laser... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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