These two devices are cleared for different problems, and neither is cleared for what the other does. CoolSculpting is cleared to break down fat in named body areas. BodyFX is cleared for the temporary reduction in the appearance of cellulite, and for minor muscle aches and spasm. There is no fat-reduction, lipolysis or circumference wording anywhere in the BodyFX clearance.
Cellulite and fat are not the same problem, and they do not sit in the same tissue. Cellulite is dimpling. It comes from the fibrous bands that tie the skin down to deeper layers. Fat is volume. Published reviews of how cellulite forms conclude that treatments aimed at those bands are the ones that produce lasting change. Targeting fat or the deeper skin layer alone gives patchy, short-lived results.
Taking fat out from under dimpled skin does not release the bands that make the dimples. That is why fat-reduction devices are not cellulite treatments. It is also why the FDA lists "improving the appearance of cellulite" as a separate cleared purpose from "reducing small areas of fat" on its own body-contouring page.
So the honest question is what you are actually looking at. A soft pad you can hold between your fingers is volume. Of these two, CoolSculpting is the one cleared to treat it. Skin that reads as dimpled, quilted or mattress-like is the other problem, whether or not there is much fat under it. Freezing fat is not a cleared treatment for that.
It was cleared on 8 October 2013 as the "InMode WMbody device", K131362. The FDA defines its product code as a device "intended to temporarily alter the appearance of cellulite". The device it was cleared against was the Viora Reaction. A 510(k) clearance means the FDA agreed the device is much the same as one already on the market. It is not a finding that the device works.
It was authorised through a De Novo request, DEN090002, decided 24 August 2010. That request created the FDA device category for cryolipolysis. Every body area since has been added by a separate 510(k).
Fat cells are more easily harmed by cold than skin, nerve and vessel. The cold inflames the fat lobules. The cells die off, and immune cells clear them over the following weeks.
That is the whole indication, word for word. No fat, no lipolysis, no circumference, no named body region. Note the word temporary, which is in the cleared wording itself. This is scoped to the clearance that was checked, K131362. InMode holds other clearances on other applicators, and some of those do carry fat wording.
The submental and submandibular areas under the chin and jaw are cleared separately, up to a body mass index of 46.2. CoolSculpting Elite is K212707, cleared 5 November 2021.
No published trial is not proof that the device does nothing. It does mean there is no published number to quote for how much it changes anything, or for how long.
Single studies ranged from 10.3% to 25.5% by ultrasound. An independent randomised split-body trial in 2023 measured about 14%. That is the thickness of the pinched fat layer at one point. It is not body fat and not weight.
Pain arriving several days late is common. A review of 554 procedures found it lasted 3 to 11 days and cleared on its own. It happened most often in younger women treated on the abdomen.
The mean was 5.6 cycles and 1.9 sessions, with a very long tail. Results are checked at 12 weeks in most of the FDA-reviewed trials.
Nothing citable exists for BodyFX from a professional society or a consumer aggregate. Any range you see is one clinic's marketing.
Those reviewers rated it 59% "Worth It". Separately, the American Society of Plastic Surgeons' last published average physician fee for non-surgical fat reduction was $1,157 in 2023. That is a per-procedure physician fee averaged across six unrelated products, not a CoolSculpting price. The society published no such fee at all in 2024.
Under the skin, fibrous bands run from the deeper tissue up to the underside of the dermis. Fat sits between them. When the bands are short or tight and the fat between them pushes up, the surface pulls into dimples. That is the mattress or cottage-cheese look.
Two published reviews of how cellulite forms reach the same conclusion. The fibrous bands are the main event: The 2020 review put it directly. Treatments aimed at fat and at the dermis do not produce lasting change, which suggests those tissues are not the main cause. Approaches aimed at the collagen-rich septae, meaning those bands, are the ones most likely to give lasting improvement. A 2023 review said the same, and named the risk factors as female sex, rising age and higher body mass index. Both reviews carry industry ties worth knowing about. Authors on the first were investigators on a manufacturer's phase-3 cellulite drug programme. The second came out of a sponsored roundtable.
The practical consequence is the one that matters here. Reducing fat volume does not shorten or release a fibrous band. Someone can lose fat in an area and still have exactly the same dimpling. Sometimes it is more obvious than before.
The devices the FDA has cleared under its dedicated cellulite category are a different set of machines again. They are Cellfina and Avéli, which cut or release the bands mechanically. BodyFX is not in that category. It sits in the older class of vacuum-and-massage devices cleared to temporarily alter the appearance of cellulite.
Both of these devices are cleared, not approved. Clearance under the 510(k) route means the FDA agreed a device is much the same as something already legally on sale. It is not a judgement that the device produces a worthwhile effect.
That matters differently for each. For CoolSculpting there is at least a large body of measured outcomes behind the wording, however uneven. The main endpoint in most of its clearances was blinded photo identification. That asks whether trained reviewers can pick out the "before" picture better than chance. It is a spot-the-difference test, not a measurement of fat. For BodyFX, no published clinical trial of the applicator could be found at all. So there is nothing to hold the wording up against.
Plenty of people have a bulge and dimpling in the same place. They are different tissue problems, so there is no conflict in principle. Nothing has been published on treating them together in this combination. One thing is worth raising with the person planning your treatment. Reducing volume under skin that is already dimpled or slack does not tighten anything, and the order you do things in can change how the result looks.
The FDA says it plainly on its own body-contouring page, last updated 15 October 2025. Non-invasive body contouring "does not treat obesity or improve your health. It will not result in weight loss." CoolSculpting's own maker safety information says the same thing. The procedure is not a treatment for weight loss, and it does not replace diet, exercise or liposuction. The body mass index limits inside the CoolSculpting clearance are a ceiling on who can be treated. They are not a target the treatment moves.
No professional society has issued a formal position statement to that effect. The regulator and the manufacturer are the sources, and they are enough.
Tell your provider if you have any of the three cold-related blood disorders that rule out cryolipolysis completely: They are cryoglobulinemia, cold agglutinin disease and paroxysmal cold hemoglobinuria. In all three, blood reacts badly to cold. That is why they sit on the maker's own safety document as absolute bars rather than cautions.
Mention a hernia at or near the area you want treated, even a small one or a repaired one: Hernia appears in the FDA's risk list for this whole device class, and in CoolSculpting's precautions. It is the single item here most likely to be skipped over, and the one most worth raising.
Disclose a pacemaker, an implanted defibrillator or any other active implant before a radiofrequency treatment: These are standard labelled exclusions for radiofrequency devices. They are there as a precaution rather than because they have been tested. The people to advise you are the team who manage the implant.
Also worth flagging in advance: cold urticaria, Raynaud's, chilblains, reduced feeling or circulation in the area, bleeding disorders or blood thinners, recent surgery or scarring in the area, and eczema or dermatitis over the site.
Fever or chills after treatment
Redness spreading outward from a treated area hour by hour
Pus or discharge from treated skin
These point to a spreading infection and need same-day urgent care.
A firm, well-defined lump appears in a CoolSculpting-treated area two to six months later, above all if its shape matches the applicator. This is paradoxical adipose hyperplasia. It does not clear up on its own, and repeat cryolipolysis has been reported to make it worse
Pain or swelling is rising after day three rather than settling
Numbness in a treated area is still there after about three months
Blistering, crusting or an open area appears
The treated skin darkens a lot over the following weeks
An area starts to look hollow or dented next to the untreated side