CoolSculpting® and CoolSculpting® Elite Uses
CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.
CoolSculpting® and CoolSculpting® Elite Important Safety Information
This procedure is not for everyone. You should not be treated with CoolSculpting® or CoolSculpting® Elite if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you are pregnant or have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, cramping and discomfort at the treatment site. These sensations lessen as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, stinging, tenderness, cramping, skin inflammation and aching. Sensory alteration (itching, skin sensitivity, tingling, and numbness) can persist up to several weeks after treatment. You may also experience throat discomfort/soreness and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may happen in 1 to 10 out of 10,000 CoolSculpting® and CoolSculpting® Elite treatments (between 0.01% to 0.1%). One such rare side effect is a visible enlargement in the treated area, which may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.
Please see full Important Safety Information for CoolSculpting® and CoolSculpting® Elite on CoolSculpting.com.
Uses and Important Safety Information for CoolTone®
Uses
The CoolTone® device is FDA-cleared in adults aged 22 years or older for:
- Strengthening, toning, and firming of the abdomen, buttocks, and thigh muscles
- Stimulating of healthy muscles to improve or help muscle performance; CoolTone® induces muscle contractions to enhance muscle function and may, therefore, be considered a method of muscle training
- Relaxation of muscle spasms, preventing or slowing muscle weakness due to lack of use, increasing blood flow to a specific area, retraining muscles, and maintaining or increasing the range of motion
- Use under medical supervision with other therapies for treating certain medical diseases and conditions
- Stimulating leg muscles for rehabilitation therapy
Important Safety Information
The CoolTone® procedure is not suitable for everyone. Do not use CoolTone® treatment in areas with metal, active, electrical, or electronic implants or devices such as cardiac pacemakers, implanted hearing aids, defibrillators, neurostimulators, or drug pumps.
Tell your doctor about any medical conditions, as CoolTone® should not be used over the uterus during menstruation, over areas of the skin that lack normal sensation, or in patients with fever, cancer, bleeding disorders, active infections, epilepsy, recent surgery, lung problems, or pregnancy.
CoolTone® should be used with caution in patients with Graves disease (an overactive thyroid condition); in women with an intrauterine device (IUD); and in patients with a hernia in or near the treatment site, active bleeding problems, or a seizure disorder. If you have an IUD and experience symptoms such as severe abdominal pain, cramping, spotting, or heavy bleeding develop during or after treatment, seek medical care right away.
Women who are close to their period may find that their period starts earlier or cramping becomes stronger with CoolTone® treatments. For this reason, it is best to avoid treatment during this time of the month.
CoolTone® is not recommended on certain parts of your body: the heart, head, neck, mouth, areas of new bone growth, or places with poor blood flow or reduced feeling. Do not use CoolTone® on skin that is swollen, infected, irritated, or has rashes. Applying it over scarred skin may raise your risk of burns. If you have or think you may have heart problems, tell your healthcare provider before using CoolTone®. Talk to them about any questions or concerns you may have before treatment.
Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and redness at or near the treatment area.
Ask your Healthcare Provider if CoolTone® is right for you.
Please see the full Important Safety Information for additional information at cooltone.com.
