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Liptron 3000, Lipo-Ex Not Approved by FDA for Weight-Loss

July 20, 2012 — The LipoTron 3000, sometimes known as the Lipo-Ex, is a medical device that uses high-frequency radio waves to target subcutaneous fat. It is promoted as a non-invasive, non-surgical procedure to “melt away” fat. Unfortunately, the device has never been approved by the U.S. Food and Drug Administration (FDA) for weight-loss.

The manufacturers attempted to gain approval for the device under the FDA’s 510(k) process, which allows fast-track approval of “substantially similar” devices without requiring the manufacturer to conduct safety studies. The FDA rejected the bid. In 2010, the manufacturers re-submitted an application claiming the device was a massager that could be used to relieve minor pain. Massagers do not need to gain FDA approval before they can be sold.

However, doctors and spas are not promoting the device as a massager, but as a way to “melt away” fat. Once a product is legally on the market, a doctor is allowed to use it “off-label” for whatever purpose he or she deems fit. Some doctors who have used the product on patients claim they were told that FDA approval was “imminent,” but it never happened.

Critics of the Lipotron 3000 say they informed the FDA of the issue in 2010. However, the FDA has not taken action against the manufacturers.

Dr. Sherwood Baxt, a New Jersey plastic surgeon, appeared in the device’s promotional material. However, he has stopped using it for fat reduction because “it wasn’t as effective as I thought it was going to be.” He now recommends it for “skin-tightening” and advocates treatment for 3 months to one year.

There have been reports of minor shocks and burns from the device, but no one has been seriously injured. Manufacturers of the device claim that it targets subcutaneous fat and visceral fat surrounding internal organs, but leaves vital organs unharmed.

Even so, the Texas Department of State Health Services sent a warning to one Fort Worth distributor in 2011. The distributor allegedly told the state that the Lipotron 3000 had been cleared by the FDA, when in fact they had only submitted paperwork.

The FDA will not say whether they are investigating the manufacturers of the device. However, FDA spokeswoman Sarah Clark-Lynn said that if a device is not on the market legally, “a physician should not have been able to obtain it, much less use it on a patient.”

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