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Unapproved lipo device penetrates market

Article-Unapproved lipo device penetrates market

Fullerton, Calif. — The LipoTron 3000, a popular aesthetic device touted for its ability to eliminate fat, is gaining popularity in some physicians’ offices around the country, but the product hasn’t been cleared by federal authorities.

Medical spas in Chicago and Florida call the LipoTron 3000 “innovative” and “effective,” but the device hasn’t achieved clearance by the Food and Drug Administration. The device, also known as Lipo-Ex, is manufactured by RevecoMED and has been falsely advertised by some practitioners as being FDA-approved, according to the Florida Center for Investigative Reporting.

According to the FCIR, the federal agency won’t say whether it is investigating RevecoMED, citing a policy not to discuss investigations or acknowledge if there is one.

RevecoMED President James S. Rosen said the government agency hasn’t contacted his company.

“As of today, we are compliant with the FDA,” Mr. Rosen told the FCIR.

The Texas Department of State Health Services issued a warning letter to a Fort Worth distributor in September 2011 regarding the company’s marketing of LipoTron without FDA clearance, FCIR reports.

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