Non-Invasive Body Contouring Technologies
On this page:
- What is Non-Invasive Body Contouring?
- Risks Associated with Non-Invasive Body Contouring Technologies
- If You Are Considering Non-Invasive Body Contouring
- Medical Device Databases
- Report Medical Device Problems to the FDA
- Resources
What Is Non-Invasive Body Contouring?
Body contouring, also known as body sculpting, refers to changing the shape of an area on your body and is used to describe a variety of effects such as:
- Changing the circumference of an area on your body like your waist or thighs.
- Changing your body’s silhouette by reducing small areas of fat.
- Improving tone and firmness of certain muscles.
- Improving the appearance of cellulite.
There are no FDA cleared or approved non-invasive body contouring devices for treating the breasts in males or females.
Body contouring procedures may not always result in your desired effect, or your result may only be temporary. Non-invasive body contouring describes non-surgical procedures that do not remove any tissue (fat or skin) from the body. It is different from a surgical body contouring procedure, like tummy-tuck surgery, which cuts out excess skin, or liposuction, which uses a narrow vacuum-type device to pull fat out through a small incision. 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.
Some non-invasive body contouring devices are designed to achieve your desired effect by decreasing small amounts of excess fat in the treated body area. This can help reduce visible bulges by reducing the amount of fat that is in the bulge. Some non-invasive body contouring procedures that are meant to only improve the appearance of cellulite, even if they do not change the shape of your body, are grouped with body contouring. Cellulite appears as large dimples, such as on the thighs and buttocks, between small mounds of soft fat. It is thought that the soft, fatty mounds are caused by extra fluid between the fat cells, while the dimples are caused by short strands of connective tissue (fibrous septae) that pull the skin down into and through the fat to connect the skin to the underlying bands or sheets of connective tissue (fascia) between the skin and muscle.
Many of the procedures result in temporary improvement in the appearance of the bulge or cellulite. Ask your health care provider how many treatments will be needed, how long the effects are expected to last, and whether additional procedures will be needed to maintain the effect.
This web page does not discuss technologies which involve putting volume into the body for body contouring. Certain dermal fillers have been approved by the FDA for certain indications such as correction of moderate to severe facial wrinkles, and for augmenting (increasing) volume of lips, cheeks, chin, and back of the hand. The FDA has not cleared any dermal filler, including silicone, for injection in body contouring procedures. Silicone injections can lead to long-term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, or death.
For more information about body contouring devices that have marketing authorization from the FDA, see the Medical Device Databases section below.
Risks Associated with Non-Invasive Body Contouring Technologies
As with any medical procedure, there are risks and complications associated with using body contouring devices. Each technology described below has its own set of risks and may have certain limitations on who can be treated safely.
Minor complications may occur shortly after a procedure and last only a short time. However, some complications may last a long time, become permanent, or require surgery to correct. If you are considering body contouring, do your research. Talk with your health care provider and read the device manufacturer information to understand your personal risk factors and whether the effect you are seeking is reasonable. Be sure to understand all your options and consider each device’s benefits, limits, and the risks involved.
Complications reported for all body contouring devices may include:
- Pain or discomfort
- Redness
- Swelling
- Bruising
- Nodules (lumpiness you can feel but not see)
Additional complications have been reported for certain body contouring devices. See the following section on non-invasive body contouring technologies for more information.
Non-Invasive Body Contouring Technologies
Non-invasive body contouring devices and procedures are performed on the skin surface. They do not involve incisions (cutting the skin). Before a non-invasive body contouring device is legally authorized for the market, the FDA reviews the safety and effectiveness of the device for the intended uses and body sites on which the device is intended for use. The technologies used in these devices are described here. The descriptions are organized by whether the technology is thermal (cools or heats tissue) or non-thermal (does not cool or heat tissue).
Thermal: Cold (Cryolipolysis or Fat Freezing)
Cryolipolysis, also referred to as fat freezing, uses cold temperatures that are intended to kill fat cells and reduce visible fat bulges without surgery. A targeted area of pinchable fat is drawn by a vacuum into an applicator, where it is cooled for up to an hour. Because fat cells are uniquely sensitive to cold, the controlled cooling is intended to kill the fat cells and not freeze the skin. The fat released from the damaged fat cells is slowly cleared by the body’s immune system, usually within two to three months. This causes the fat bulge to become smaller over time. Devices that use this technology are for prescription use only. The safety and effectiveness of over-the-counter or home use fat freezing has not been established.
You should not have a fat freezing procedure if you have one of the following cold sensitivity disorders that can affect the blood or skin:
- Raynaud’s disease, pernio, or chilblains—conditions in which cold temperatures cause poor blood circulation in the skin
- Cold urticaria—a condition in which exposure to cold causes hives
- Cryoglobulinemia—a condition in which clumps form in your blood when you are exposed to cold
- Paroxysmal cold hemoglobinuria or cold agglutinin disease—disorders in which red blood cells are damaged by cold temperatures
- Poor blood circulation in the area to be treated
After a fat freezing procedure, some patients may develop complications at the treatment site.
Common complications that may resolve without intervention:
- Redness
- Bruising
- Swelling
- Pain or discomfort
- Skin discoloration
Less common complications that may require intervention and may have long-term effects:
- Numbness that can persist for several weeks
- Nodules (small, temporary lumps in the fat that can be felt but not seen)
- Freeze burns on the skin, which can be severe (partial or full thickness burns)
- Damage to a nerve that causes a temporary change in the position of the lip or tongue, if used under the jawline
- Temporary sensation of fullness at the back of the throat, if used under the chin
Least common but more serious complications that may require surgery to be addressed. Surgery may or may not resolve these complications:
- Paradoxical Adipose Hyperplasia (PAH) is a phenomenon in which fatty tissue grows instead of shrinking in the treated area. PAH is a raised, often rectangular bulge of hard, fatty tissue. It is very firm and is usually the same shape as the treatment applicator. PAH is unique to fat freezing. Reported cases developed two to five months after a fat freezing procedure. PAH does not go away on its own and may require surgery to remove the visible bulge.
- Hernia is a bulging of an organ or tissue through a weak area in the abdomen or abdominal wall lining. There have been reports of hernias in the treated area after a fat freezing procedure. The procedure should not be performed in or near the area of a pre-existing hernia or structurally weak areas, such as surgical scars or the separation between the stomach muscles, commonly seen after pregnancy.
Thermal: Heat
Fat bulges are also affected by gentle heating when heat is applied to an area without burning the skin.
Heating for non-invasive body contouring is thought to:
- Damage the fat cells in the layer of fat under the skin and reduce the thickness of fat in the treated area.
- Shrink parts of the skin, including the fibrous septae under the skin, to reduce dimples in cellulite. Fibrous septae are the short strands of connective tissue that pull the skin down into and through the fat to connect the skin to the underlying bands or sheets of connective tissue (fascia) between the skin and muscle.
- Trigger the skin to produce collagen to give the skin a tighter appearance.
- Temporarily improve circulation to remove fluid buildup outside of the fat cells and reduce the bumpy appearance of cellulite.
Heat Technology Examples:
Radiofrequency Energy
Electrical energy, in the form of radiofrequency (RF) energy, causes heating. When RF energy is carefully applied to the skin, it can cause heating in the layer of fat under the skin and in the strands that connect the skin to the fat layer. Some devices use tiny needles to place the RF energy into the skin. Procedures that apply RF energy can temporarily improve the appearance of cellulite or reduce the circumference of your body in the treated area. They may also cause the skin to feel or look tighter because of some skin shrinking or increases in collagen. Not all RF devices that may be on the market are intended for cosmetic use. Only devices intended for cosmetic use and authorized for marketing by the FDA for such use should be used to achieve these body contouring effects.
Do not use RF energy devices if you have:
- Active implants, such as a pacemaker or an implanted cardioverter defibrillator
- Metal under your skin from an implant or injury
- Tattoos with ink that contains metal particles in the treated area
If you have an intrauterine device (IUD) for birth control, ask your obstetrician-gynecologist or primary care provider if the procedure may pose additional risks for you.
Complications may include:
- Pain or discomfort
- Redness
- Swelling
- Blisters
- Burns
- Nodules
- Change in skin color
- Scars
Light-Based Energy
Some body contouring devices use powerful light, such as lasers or intense pulsed light (IPL), to heat tissue. Most often the device will use infra-red (IR) light, which is not visible to the human eye. Carefully controlled application of IR light can cause heating under the skin without burning the skin surface. The heating is thought to damage fat cells and to cause some shrinking of the short strands of connective tissue that connect the skin to fat and deeper tissues beneath. Because of these heating effects, IR light procedures may temporarily improve the appearance of cellulite or reduce the circumference of the body in the treated area.
Light-based energy procedures can injure the eyes. Your health care provider should give you protective goggles to wear during the procedure.
Light-based energy procedures may not be appropriate for you if you:
- Are tan or planning to be in the sun after the procedure
- Have skin that develops dark marks after any injury
- Have a sensitivity to light or take medications that make you sensitive to light
Complications may include:
- Pain or discomfort
- Redness
- Swelling
- Blisters
- Burns
- Nodules
Ultrasound
Ultrasound uses sound waves with frequencies higher than the upper audible limit of human hearing. Ultrasound may be used therapeutically to treat tissue. During a therapeutic ultrasound procedure, a sound wave (energy) is applied to the skin surface. When the energy enters the fat layer beneath the skin, it can cause fat cells to rupture, which may reduce the circumference of the body in the treated area.
Therapeutic ultrasound can cause burns in tissue. Ultrasound requires complete contact with the skin. Your health care provider will put ultrasound gel on the skin to make sure there is good contact and to reduce the risk of burns.
Do not have an ultrasound procedure if you have:
- Open wounds or lesions
- Compromised skin surfaces
- Active implants, such as a pacemaker or an implantable cardioverter defibrillator
- Metal under your skin from an implant or injury
Complications may include:
- Pain or discomfort
- Redness
- Swelling
- Blisters
- Burns
- Nerve damage
Non-Thermal
Photobiomodulation (Low-Level Light)
Low-level light therapy (LLLT) procedures, which are different from the laser and IPL devices, use extremely low doses of visible light that do not heat the skin or fat. Usually, these devices have several lamps or LED panels which are placed near the body and may not even touch the body. LLLT devices are thought to work by photobiomodulation, which means they may change the way a cell works with just a small amount of light, without any change in temperature. LLLT may temporarily reduce circumference of the body in the treated area.
Light-based procedures can injure the eyes. Your health care provider should give you protective goggles to wear during the procedure.
Photobiomodulation therapy is not recommended if you:
- Have photosensitivity disorders
- Are pregnant or planning pregnancy
- Have active implants, such as a pacemaker or implantable cardioverter defibrillator
- Have skin cancer or a history of cancer at the treatment site
- Are taking photosensitizing medication
- Have an active infection, wound, or lesion in the area to be treated
There are few risks of complications because the energy level is extremely low. Some procedures are performed while you are dressed, so the dose to the skin is even lower.
While rare, some complications may include:
- Sensitivity at the treatment site
- Electrical malfunction leading to injury
- Burns
- Skin pigmentation changes
- Itching
- Nodules
- Pain
Magnetic Field
Pulsed magnetic fields work by triggering a small electric current in the muscles. This short, low energy current causes muscles to contract. Repeated muscle contraction during the procedure may improve muscle tone and firmness of the abdominal muscles and muscles of the arms, or strengthen, tone, and firm the buttocks, thighs, and calves. These effects may be temporary and may require you to have ongoing procedures to maintain the effects.
Do not use magnetic field devices if you have:
- Active implants, such as a pacemaker or an implantable cardioverter defibrillator
- Metal under your skin from an implant or injury
Complications may include:
- Muscle soreness
- Cramps
Mechanical (Massage or Vibration)
Massaging the skin and fat, using a rolling or vibrating handpiece, may temporarily improve the appearance of cellulite on the body in the treated area. Sometimes a handheld “shock wave” device may be used to cause vibration like a small jackhammer. Pressure and vibration are thought to work like a lymphatic massage, by removing the extra fluid between the fat cells and improving the bumpy appearance of cellulite. Stretching the skin may also trigger collagen formation and may give the skin a more youthful appearance.
Do not undergo this procedure if you have conditions such asvibrational or pressure urticaria (itching or burning) that cause allergic symptoms or hives to develop with vibration or pressure.
Complications may include:
- Pain or discomfort
- Bruising
If You Are Considering Non-Invasive Body Contouring
- Understand that while noninvasive body contouring may be performed in a variety of facilities, noninvasive body contouring is a medical procedure with benefits and risks.
- Talk with your health care provider about the benefits and risks associated with body contouring devices and procedures.
- Talk with your health care provider about which procedures may be best for you. For individuals with darker skin types there is a potential of darkening or lightening of the skin after a body contouring procedure.
- Read any available patient brochures to understand your personal risk factors and whether the effect you are seeking is reasonable. Take time to read the information and ask questions.
- Understand that any body contouring device could potentially cause complications. Most complications occur shortly after a procedure and may last only a short time. However, some complications may last a long time, become permanent, or require surgery to correct.
- Know that non-invasive body contouring is not intended to treat obesity or to improve your health. It will not result in weight loss or contribute to the health benefits associated with weight loss.
- Understand that not everyone responds to body contouring procedures or achieves their desired effect, results may be temporary, and you may need more than one treatment.
- Ask the health care provider who is performing your procedure how they clean devices between patients and whether there are any disposable parts. If they use disposable parts, ask whether a new disposable piece is used for each procedure session.
- Inform the health care provider who is performing your procedure:
- About all medications you take, including over-the-counter supplements and vitamins.
- If you have any implanted medical devices, including a pacemaker, artificial joints, or metal implants or screws.
- If you have an intra-uterine device (IUD), contraceptive coil, mesh, tattoo, scar, cosmetic implant, or have had surgery in the treatment area.
Tell your health care provider if you:
- Take anticoagulant (blood thinner) therapies.
- Are immune deficient or immune suppressed because of a medical condition or medications.
- Have a known history of clotting or bleeding disorders such as hemophilia.
- Have uncontrolled diabetes (high blood sugar).
- Have an active skin infection, including bacterial, viral, or fungal infection.
- Have an infection such as hepatitis or human immunodeficiency virus (HIV).
- Have or had eczema, psoriasis, vitiligo, or autoimmune disease.
- Have keloids or a family history of keloids (very prominent scars).
- Have an active rash, wart, mole, or birthmark on the area to be treated.
- Have a known malignancy or are undergoing or about to undergo treatments using chemotherapy, radiotherapy, or steroids.
- Are currently taking acne medication with the ingredient isotretinoin (Accutane) or have taken isotretinoin in the past six months.
- Are tan or planning to be in the sun in the two weeks following the procedure.
- Are pregnant or breastfeeding.
- Are allergic to stainless steel or to plastic or rubber additives or have a history of allergic contact dermatitis to these products.
Medical Device Databases
The FDA posts summary documents describing the clearance of certain medical devices in the 510(k) Premarket Notification database and the marketing authorization of certain novel medical devices in the De Novo database. These summary documents include the date the device received marketing authorization by the FDA, the indication for which the device was authorized by the FDA, and a summary of the information submitted to the FDA.
- In the De Novo database – You can search for a device by the device name, manufacturer, or panel (e.g., General & Plastic Surgery).
- In the 510(k) Premarket Notification database – You can search for a device by the device name, manufacturer, or product code. The product codes for body contouring technologies are provided in the table below.
| Technology | Product code | Regulation (21 CFR) | Device Type |
|---|---|---|---|
| Cryolipolysis | OOK | 878.4340 | Cooling with vacuum for body contouring |
| Radiofrequency Energy | GEI | 878.4400 | Electrosurgical (including RF) |
| Radiofrequency Energy | PBX | 878.4400 | Vacuum massager with RF-induced heating |
| Light-based Energy | GEX | 878.4810 | Powered laser surgical instrument |
| Light-based Energy | PKT | 878.5400 | Laser for disruption of fat for aesthetic use |
| Ultrasound | OHV | 878.4590 | Focused ultrasound for tissue heat or cell disruption |
| Low level light (laser) | OLI | 878.5400 | Low level light (laser) for fat reduction |
| Magnetic Field | NGX | 890.5850 | Muscle stimulator |
| Mechanical (Massage or Vibration) | NUV | 878.4810 | Vacuum massager with light-induced heating for cellulite appearance |
Report Medical Device Problems to the FDA
If you have a problem with or after the use of any medical device, we encourage you to report the problem through the FDA’s MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.