A New Noninvasive Device for Cellulite Treatment Was Just Cleared by the FDA
Cellulite on the body is like melasma on the face: It’s not one-size-fits-all, it’s incredibly difficult to treat, and dermatologists don’t have a tried-and-true method to get rid of it—for good. Well, not yet anyway. If we can send people to the moon, you’d think we can banish those stubborn fatty pockets that can make our legs look like cottage cheese, but it’s a tricky, tricky battle that has yet to be won.
Today, a medical device company called Soliton has announced it is joining the fight with its proprietary, innovative Rapid Acoustic Pulse (“RAP”) technology that just received its 510K clearance from the FDA for the short-term improvement in the appearance of cellulite. Using the power of sound, the treatment delivers high-pressure acoustic pulses—100 per second—to the targeted area to break apart the fibrous septa bands beneath the skin’s surface the create that infamous puckered look.
It’s important to note that the FDA’s 510k clearance is “a premarket submission and demonstrates that the device is at least as safe and effective as another legally marketed device. It is not a statement of superiority of results compared to current devices,” says Englewood, NJ plastic surgeon Shwetambara Parakh, MD.
According to Soliton, patient results in clinical trials were “generated by a single, noninvasive treatment that required no anesthesia, caused no unexpected or serious adverse events, received strong patient satisfaction ratings, and was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10.” Brad Hauser, president and CEO of Soliton, says the FDA clearance marks the next step in the planned commercialization of the company’s RAP technology, and rollout to physicians will begin this spring.
Dr. Parakh has not used the device, but after reviewing the available materials, she says more research is needed before she can determine its efficacy. “One study done on 67 patients—data for which has not been published yet in a peer-reviewed journal—and at the 12-week follow-up, before-and-after photos were assessed by ‘blind’ reviewers,” she explains. “Only 84 percent of the time they were able to correctly identify before-and-after unlabeled photos, which means that 16 percent of the time, the reviewers did not see any difference between the pre- and post-treatment photos. Emerging technology definitely excites me, but early review of the limited data available with this technology leaves much to be desired.” Stay tuned to NewBeauty for updates on this technology and other cellulite-smoothers.
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