If you’re thinking about trying CoolSculpting® Elite,
here are a few things you should know.
CoolSculpting® ELITE is a fat-reduction treatment for men and women who want to get rid of stubborn pockets of fats in certain areas of their body (see FDA-cleared areas for treatment) 6. CoolSculpting® ELITE is NOT a weight loss procedure. CoolSculpting® ELITE is a nonsurgical alternative that has little downtime6 with lasting results.
CoolSculpting® ELITE is 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 and buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments6.
The applicator will be placed on the treatment area, and there will be a slight sucking sensation as it adheres to your body followed by that signature cooling effect. During the procedure, you may experience sensations of pulling and intense cold. These sensations subside as the area becomes numb13. After the treatment, you may feel some tingling as the area is massaged for approximately 2 minutes. Patients are usually able to return to normal activities following their treatment. What to Expect has more information about what happens before, during and after your CoolSculpting Elite procedure.
Each CoolSculpting® ELITE treatment is different, so it depends on which areas of the body and how many of them you plan on doing. Depending on the area, treatment can be done in as little as 35 minutes13. If you opt to do multiple treatments in a session, expect to spend more time. The CoolSculpting® ELITE machines feature dual applicators, allowing patients to do multiple treatment areas at once, reducing the amount of time spent in center as compared to using 1 CoolSculpting applicator.
While you will see up to a 27% fat reduction in the treated area after a single treatment6, it depends on the person and they are being treated. Your provider will work with you to determine if additional treatments are necessary to reach your desired goal.
You’ll start to see changes as soon as 1-3 months posttreatment.10
See the fat-reduction results up close with our Before & After gallery. Check out the results of real patients to see how CoolSculpting® helped shape their bodies after several weeks.6
CoolSculpting® ELITE uses cryolipolysis, which is just a technical way to say fat freezing. When fat cells freeze, they die and are then naturally eliminated through the body’s natural process. Don’t worry. This process happens so gradually, you won’t necessarily notice a difference in your day-to-day life.
Read more about the science of cryolipolysis here.
CoolSculpting® ELITE has been cleared by the FDA to safely and effectively treat 9 different areas of the body (see the FDA-cleared areas below).6
The CoolSculpting® ELITE treatment is not for everyone. You should not have it done if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria13. The CoolSculpting® ELITE procedure is not a weight loss treatment. As with any medical procedure, ask your physician if CoolSculpting® ELITE is right for you.
The CoolSculpting® ELITE treatment helps eliminate stubborn pockets of fat. But, since CoolSculpting® ELITE is not a weight loss treatment, it is possible to gain weigh posttreatment if you don’t keep up your healthy habits. This kind of weight gain will most likely happen evenly throughout your body, not just in treatment areas.
Learn more about the difference between fat loss and weight loss here.
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.
Important safety information:
During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching and cramping at the treatment site.13 These sensations subside as the area becomes numb.13
Following the procedure, typical side effects include redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, skin sensitivity and numbness. Numbness can persist for up to several weeks. A sensation of fullness in the back of the throat may occur after submental treatment. The following rare and very rare side effects have the following incidence rates (approximate occurrences per number of treatments): paradoxical hyperplasia (1/3000 [0.033%]); late-onset pain (1/6000 [0.017%]); severe pain (1/6000 [0.017%]); hyperpigmentation (1/11000 [0.009%]); freeze burn (1/15000 [0.006%]); treatment area demarcation (1/20000 [0.005%]); vasovagal symptoms (1/30000 [0.003%]); subcutaneous induration (1/30000 [0.003%]); cold panniculitis (1/60000 [0.002%]) and hernia (1/185000 [0.001%]).13,15 The CoolSculpting® procedure is not for everyone. Patients should not have the CoolSculpting® procedure if they suffer from cryoglobulinaemia, cold agglutinin disease or paroxysmal cold haemoglobinuria.13 The CoolSculpting® procedure is not a treatment for obesity.14 CoolSculpting® is not a weight loss procedure and should not replace a healthy diet and active lifestyle.
Please see CoolSculpting® and CoolSculpting Elite® Important Safety Information for additional information.
Effect of treatment varies with individuals
- Medical Insight Inc. The Global Aesthetic Market Study: Version XVII. 2019
- All time International Cycles Summary_040621. Data sourced from Connect Cube database [provided by International Business Excellence]. May 2021.
- Manstein D et al. Lasers Surg Med 2008; 40: 595-604
- Zelickson B, et al. Derm Surg 2009; 35:1462-70
- Allergan Inc. Unpublished Data. CoolSculpting® Publications. INT-CSC-2050471. December 2020.
- Sasaki GH, et al. Aesthet Surg J 2014; 34:420–31
- Allergan. Unpublished data. INT-CSC-2050028. CoolSculpting® clinical “Fit and Function” study to test the V003 wells. February 2020.
- Allergan. Unpublished data. INT-CSC-2050288. Applicator cooling and distribution dye test. August 2020.EN-A.
- Allergan. CoolSculpting® system (CoolSculpting® ELITE) user manual. CS-UM-CM3-04-EN-A. 2020.
- Manstein D et al. Lasers Surg Med 2008; 40: 595-604
- Avram MM and Harry RS. Lasers Surg Med 2009; 41:703-8
- Krueger N, et al. Clin Cosmet Investig Derm 2014; 7:201-25
- Allergan, CoolSculpting® System User Manual. BRZ-101-TUM-EN6-K
- FDA 510(K) Summary Document. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193566.pdf [Accessed November 2021].
- Allergan Inc. US CoolSculpting® Important Safety Information. November 2021. Available at: https://www.coolsculpting.com/pdfs/CSC125713-v3-CoolSculpting-Important- Safety-Information.pdf [Accessed November 2021]