CoolSculpting: what it is, what the FDA says, what to ask

MedSpaGrades editorial teamUpdated 22 Oct 20262 sources checkedHow we write

CoolSculpting is a product name for cryolipolysis, often called fat freezing. This page says what the FDA and the American Society for Dermatologic Surgery (ASDS), a society of dermatologists who do surgery, say about it. It does not say whether you should have it, and it is not a weight-loss treatment.

What it is

ASDS says cryolipolysis, also known as fat freezing or by the product name CoolSculpting, is a non-invasive procedure that cools body fat to break down fat cells, reducing body fat without damaging other tissues. The FDA says a targeted area of pinchable fat is drawn by vacuum into an applicator and cooled for up to an hour, that fat cells are unusually sensitive to cold, and that the controlled cooling is intended to kill the fat cells and not freeze the skin. It says the fat released from the damaged cells is slowly cleared by the immune system, usually within two to three months.

What it is not

The FDA says non-invasive body contouring does not treat obesity or improve your health, and will not result in weight loss or give the health benefits that come with weight loss. It says body contouring may not always give the desired result, and that results may be only temporary. It says there are no FDA-cleared or approved non-invasive body contouring devices for treating the breasts in men or women. The FDA also says it is different from surgery such as tummy tuck or liposuction.

Visits and results

ASDS says cryolipolysis has no recovery time, that people can resume normal activities the same day, and that it typically requires multiple sessions. It says a visible decrease in fat bulges appears in two to four months. The FDA says not everyone responds, results may be temporary, and you may need more than one treatment, and it suggests you ask how many treatments will be needed and how long the effects are expected to last.

Risks, from the FDA

The FDA says devices that use fat freezing are for prescription use only, and that the safety and effectiveness of over-the-counter or home-use fat freezing have not been established. It says common complications that may resolve without intervention are redness, bruising, swelling, pain or discomfort and skin discoloration. Less common ones that may need intervention and may have long-term effects include numbness lasting several weeks, small temporary lumps in the fat, freeze burns on the skin that can be severe, and, if used under the jawline, a nerve injury that temporarily changes the position of the lip or tongue, or a sensation of fullness at the back of the throat.

The FDA lists two least common but more serious complications that may need surgery. Paradoxical adipose hyperplasia (PAH) is a growth of firm, hard fatty tissue, often a rectangular bulge shaped like the applicator, instead of shrinking, which the FDA says is unique to fat freezing, was reported two to five months after treatment, does not go away on its own and may need surgery. There have also been reports of hernias in the treated area. The FDA says the procedure should not be done in or near a pre-existing hernia or structurally weak areas, such as surgical scars.

Who should not have it, according to the FDA

The FDA says you should not have a fat freezing procedure if you have one of several cold sensitivity disorders that can affect the blood or skin, such as Raynaud's disease, cold urticaria, cryoglobulinemia or cold agglutinin disease, or if you have poor blood circulation in the area. It also lists things to tell your provider: all your medicines and supplements, implanted devices, an IUD or other implant in the area, previous surgery in the area, blood thinners, a weakened immune system, clotting or bleeding disorders, uncontrolled diabetes, active skin infection, keloids, and other conditions. It says people with darker skin types may risk darkening or lightening of the skin.

Who does it

The FDA says non-invasive body contouring may be performed in a variety of facilities, but is a medical procedure with benefits and risks. It says to ask how devices are cleaned between patients and whether a new disposable piece is used for each session. Which licensed professionals may operate the device depends on the state. See our guide to who may inject. For another approach to a different area, see Kybella.

What it costs

We do not give prices on this page. Our cost guide will cover how clinics quote CoolSculpting.