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FDA considering new 510(k) approval category for non-invasive 'fat burning' laser (Zerona)

"Fat Burning" is in quotes here because while we all know that low level lasers are non-thermal, the news media has adapted this slightly inaccurate term to describe the Zerona laser.  I guess "Laser Fat Zap" or "Fat Burning Laser" sounds better than 'fat leaking' -- which is, in fact, what the low level lasers in Zerona causes adipocytes (fat cells) to do... leak.

There are some rumblings from the FDA that regarding the Zerona laser, which has been demonstrated in scientific clinical trials to significantly decrease body circumference in two weeks, they (the FDA) are considering creating a 'new' category within the "Low Level Laser / Photobiomodulation" division of their 510(k) market approvals to reflect body-contouring and fat reduction. 

This has absolutely nothing to do with the specifications or safety of the Zerona device, but rather the proven body contouring effect Zerona demonstrated in the clinical trials.   So much for those people who believe that FDA 510(k) clearance is only about safety!   An FDA 510(k) approval is typically based on a predicate or pre-existing device, but because none such device exists that non-invasively reduces fat like Zerona, a new category will likely have to be created.   

We'll know within the next few weeks the FDA's decision.   For clarification, the laser in the Zerona device has already received 510(k) market approval from the FDA for use as an adjunct to Liposuction.   However, the studies submitted to the FDA show that the Zerona can be used non-invasively to significantly reduce the circumference of the hips waist and thighs without surgery, in two weeks.

For more information on Zerona lasers in Florida, visit or  

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