Fat freezing reached the market through a De Novo request. On August 24, 2010, FDA granted Zeltiq’s application for its dermal cooling device and created a new Class II category, “contact cooling system for aesthetic use,” with special controls. CoolSculpting clearances followed from 2012, and openFDA lists 14 clearances under that product code. A clearance covers a device and an intended use. It is not permission to say anything you like about the result, and FDA’s own consumer page draws the lines many contouring ads cross.
It is not weight loss. FDA says non-invasive body contouring does not treat obesity or improve health, and will not result in weight loss or the health benefits that come with it. A headline that leads with the scale is arguing with the regulator.
It is a prescription device. FDA describes cryolipolysis devices as for prescription use only, and says the safety and effectiveness of home fat freezing has not been established. Who may operate a device, and under whose supervision, is set state by state, and we have not found one rule that covers every device. California’s medical board requires physician ownership for any business selling laser and other cosmetic medical services, and says estheticians may not perform laser or IPL treatments under any circumstances. Texas leaves lasers and pulsed light devices to the Department of State Health Services, and allows a physician to hand medical acts to trained staff working under that physician’s supervision. Florida registers laser devices through its Bureau of Radiation Control. For fat freezing and radiofrequency, confirm your own state’s rule before an ad names who treats.
Some areas are off the menu. FDA says no non-invasive body contouring device is cleared or approved for treating the breasts, in men or women. Any offer to contour the chest needs a hard look before it runs.
The rare side effect has a name. Paradoxical adipose hyperplasia, in FDA’s words, is fatty tissue that grows instead of shrinking in the treated area. The cases FDA describes appeared two to five months after treatment, the condition does not go away on its own, and it may require surgery.
The marketing that follows from all this is simple to describe and rare to find: name the device and what it is cleared for, name the clinician, give the session count and the timeline, and put the risks where a client can read them before the consult. A client who has read FDA’s page will notice which studio says the same things it does.
