Vanquish is a radiofrequency field that never touches you. CoolSculpting is a cold plate that clamps onto you. BTL's Vanquish sends a selective radiofrequency field from panels held above the skin. It heats the abdomen without contact. CoolSculpting draws a fold of tissue into an applicator and chills it for 35 to 60 minutes. The two could hardly feel less alike.
The honest headline on Vanquish is about paperwork. FDA does not publish a link between BTL's trade names and its clearance numbers. So no record confirms which filing "Vanquish" is sold under. A search of the FDA 510(k) database for a device named "Vanquish" returns one record, and it is an unrelated urology device from another company. BTL holds 49 510(k) records in all.
Two BTL radiofrequency clearances do carry body claims of the right shape. K143559 covers the XP1000 RF and was decided on 11 June 2015. It is cleared for "temporary reduction in circumference of the abdomen". K152731 covers the XP1100 RF and was decided on 20 July 2016. It is cleared for "temporary reduction in circumference of the abdomen and thighs". Note what those say and do not say. They describe a temporary reduction in circumference. They do not say lipolysis, and they do not say fat reduction. Whether either is the machine in the room is a question for the clinic, so ask for the K-number.
A 510(k) clearance is a finding that a device is much the same as one already on sale. It is not a finding that the device works. That is true of every number on this page, on both sides of it.
CoolSculpting's paperwork, by contrast, is easy to follow. There is a De Novo authorisation granted 24 August 2010, then thirteen later 510(k) clearances. Each one names the body areas it added and the body mass index limits that apply. Whatever you think of the results, the record of what it may claim is on the FDA's website and can be read in full.
It is marketed as a selective field. The energy is described as gathering in fat rather than in the skin above it.
It was authorised through a De Novo request, DEN090002, decided 24 August 2010. That request created the FDA device category for cryolipolysis.
A published study of the technology reported human fat cells dying right after exposure to a high-frequency focused radiofrequency field.
Fat cells are more easily harmed by cold than skin, nerve, vessel or muscle, because of the lipid they hold.
FDA does not publish which trade name goes with which BTL filing, so ask the clinic for the K-number of the machine it will use. Read the wording closely. It says temporary, and it says circumference, not fat. Other BTL records are cleared for other things: two for periorbital wrinkles, two for shortwave diathermy deep heating, and one whose name mentions "radiofrequency module" is in fact a low-level laser clearance.
CoolSculpting Elite is K212707, cleared 5 November 2021. Under the chin and jaw are cleared separately, up to a body mass index of 46.2. The wording of the indication matters more than the existence of the number.
Thirteen patients were recalled four years after treatment. In the original study they had lost 5.88 cm of waist circumference. They had also lost 1.29 kg of body weight. At four years they were 4.42 cm below baseline, having since gained 0.50 kg. That is about 75 per cent of the original effect kept. Blinded reviewers picked the baseline image correctly in 82.1 per cent of cases.
Blinded photo picking is the main endpoint in most CoolSculpting clearances. It is a spot-the-difference test rather than a measurement of fat. The FDA's own pooled review inside K160259 put mean ultrasound reduction at 20.6 per cent, across a range of 10.3 to 25.5 per cent. An independent randomised split-body trial found about 14 per cent.
Nothing is clamped on, so it does not need a bulge to grip. But the published work is on the waist and abdomen, not elsewhere.
The vacuum cup needs tissue to draw in.
No maker's instructions for use were available to check for labelled precautions. Ask the clinic for them directly.
Delayed pain arriving a few days later is common. One review of 554 procedures found it lasted 3 to 11 days.
That figure comes from clinic pages, not from a maker's document or a trial. Treat it as what clinics offer, not as a studied protocol.
In the largest real-world review, covering 3,262 patients, the median was 4 cycles and 1 session per patient.
The RealSelf page for Vanquish ME carries an 80 per cent "Worth It" rating, last updated 29 December 2023. It states no review count and no cost figure at all. Vanquish was one of six products pooled into the $1,157 category average in the American Society of Plastic Surgeons 2023 fee table. The others included an injectable and a muscle stimulator. That is a category figure, not a Vanquish price, and the society stopped publishing the line after 2023.
It is priced per cycle rather than per session.
It is worth being exact here, because the wording is easy to over-read in either direction.
What they say: K143559, for the XP1000 RF, is cleared for "temporary reduction in circumference of the abdomen". K152731, for the XP1100 RF, is cleared for "temporary reduction in circumference of the abdomen and thighs". Both are held by BTL Industries. Both sit in the same FDA product code.
What they do not say: Neither one claims lipolysis. Neither one claims fat reduction. Neither one claims a lasting change. The word in both is temporary, and the thing being reduced is a tape measurement around the body, not the thickness of a fat layer and not fat volume. Those are four different things, and a clearance that names one of them has not been granted for the others.
What is still open: FDA does not publish a link between BTL's trade names and its clearance numbers, so no public record says which filing Vanquish is sold under. That is a gap you can close in about five minutes. A clinic that owns the machine can read you the regulatory number off its labelling. You can then look that number up in the FDA's public 510(k) database and read the Indications for Use yourself.
What is the FDA 510(k) number for the exact device you will use on me?: Not the brand. The number.
What does the Indications for Use section say, word for word?: The wording is the claim. "Deep heating for the relief of pain and muscle spasm" is a very different indication from "temporary reduction in circumference of the abdomen", even if the machine in the room is the same one.
Does that wording name fat, lipolysis or circumference - or only heating?: If it names only heating, the fat result is not something the device was cleared on.
Which body area does it name?: Clearances in this field are usually tied to named areas.
Is what you are proposing inside that wording?: Treating outside a cleared indication is legal for a clinician, and common. But you are entitled to know when it is happening.
These are fair questions anywhere, for any device on this page.
There is published work on the device, and one piece of it is unusually long: Fritz and Salavastru recalled thirteen patients four years after treatment. The device is named in the paper. In the original study those patients lost 5.88 cm of waist circumference. At four years they were still 4.42 cm below baseline, about three quarters of the original effect, even though they had gained half a kilogram in between. Blinded reviewers picked the baseline photograph correctly 82 per cent of the time.
Two things temper it. Thirteen people is a very small group. This was also a recall of patients who could be reached, not a group followed from the start. And in the original treatment period those patients lost 1.29 kg of body weight. So part of the 5.88 cm belongs to the weight loss rather than to the device. The four-year figure is the more interesting one, precisely because the weight had gone back up.
Other published work on contactless radiofrequency for abdominal fat exists. It includes magnetic resonance imaging case work, and a study of human fat cells dying right after exposure. Several of those papers sit in journals with strong industry ties. Each one needs its conflict-of-interest statement read on its own before it is treated as independent.
The FDA says it directly on its non-invasive 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 or contribute to the health benefits associated with weight loss." CoolSculpting's manufacturer says in its own safety information that the procedure is not a treatment for weight loss.
That framing comes from the regulator and from the manufacturers. It does not come from any professional society position statement. It is also why the Vanquish four-year study matters more than the original result. Telling apart what a device did from what the person's weight did is the central difficulty in this whole field, and most studies do not manage it.
Ask for the device's regulatory number and read the indication yourself: For Vanquish this is the single most useful thing you can do before spending money, for the reasons set out above.
Radiofrequency and implanted electronics do not mix well: Tell your provider about a pacemaker, an implantable defibrillator, or metal implants near the area. No maker's instructions for use for Vanquish were available to check for labelled precautions. Ask the clinic to show you the ones that came with the machine.
For CoolSculpting, three blood disorders rule it out completely: They are cryoglobulinemia, cold agglutinin disease and paroxysmal cold hemoglobinuria. In all three, blood reacts badly to cold. Disclose in advance any cold urticaria, Raynaud's disease, pernio or chilblains. Do the same for any bleeding disorder or blood thinner, reduced feeling or poor circulation in the area, and any hernia in or next to the treatment site. Hernia is named on the FDA's own risk list for this class and on the maker's precaution list.
Fever or chills after treatment
Redness around a treated area that is visibly spreading hour by hour
Pus or discharge from treated skin
These are signs of a spreading infection and need urgent care the same day.
A firm, well-defined lump appears in a CoolSculpting-treated area two to six months later, above all if it matches the shape of the applicator
A blister, a burn or an open area appears on skin after a radiofrequency treatment
Numbness in a cooled area is still there after about three months
Pain in a treated area is rising rather than settling after the first two weeks
An area starts to look hollow, dented or uneven next to the other side
The skin over a treated area darkens a lot over the following weeks
The firm lump on that list is paradoxical adipose hyperplasia. It is a rare complication of cryolipolysis in which the treated area gets bigger instead of smaller. It does not clear up on its own, and correction is surgical. Published incidence estimates disagree by about a hundredfold, largely because some count cycles and some count patients.
This complication belongs to cold, not to radiofrequency. One case has been reported after a radiofrequency device. There is no incidence figure and no case series for it.