If you’re thinking about trying CoolSculpting® Elite,
here are a few things you should know.

CoolSculpting Elite is a treatment that uses cryolipolysis technology and is designed for people who wish to eliminate stubborn localised fat. However, it is not suitable for everyone. At the initial consultation, your medical history will be obtained to determine if you are suitable for the treatment. It is important to be proactive and tell them if you have cryoglobulinemia, cold agglutinin disease, or paroxysmal cold haemoglobinuria1. If you have any of these conditions, you are not suitable for this treatment, which is not a weight loss programme and should not replace a healthy diet and exercise. Professional assessment is recommended before proceeding with treatment.

The treatment head will be placed on the site to be treated and you will start to feel the suction and a cold sensation at the beginning of the treatment. During the treatment, you may feel a cold sensation due to a specific low temperature or a slight pulling sensation due to suction, which varies from person to person, but these sensations will soon subside. Upon completion of the treatment, you will be given a massage for about 2 minutes1 and you will be able to move around as usual after the treatment.

Depending on the needs of each treatment area and the number of treatments required, it takes minimum 35 minutes to complete one area. It will take longer if you choose to have several treatments. Compared to the previous one treatment head, the new CoolSculpting Elite offers double treatment result in the same amount of time - using two treatment heads for two different sites concurrently to save time.

As the treatment is non-invasive and non-surgical, the recovery period is very short5,6. After the treatment, you can go back to your normal activities, and if you’re working, you can take advantage of your lunch break to attend the treatment.

Generally speaking, the results will gradually appear within 2 to 3 months after the treatment3,4. Of course, additional treatments may be required to achieve even better results.

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Intended Use:
The CoolSculpting® Elite System is a non-invasive cooling and heating device that applies controlled cooling or heating to a treatment site on the patient's skin. Uses of the system in cooling mode include:

  • Fat layer reduction through cold assisted lipolysis.

    The optional massage function can also be used for temporary:
  • Reduction in the appearance of cellulite.

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

References:

  1. Medical Insight Inc. The Global Aesthetic Market Study: Version XVII. 2019
  2. All time International Cycles Summary_040621. Data sourced from Connect Cube database [provided by International Business Excellence]. May 2021.
  3. Manstein D et al. Lasers Surg Med 2008; 40: 595-604
  4. Zelickson B, et al. Derm Surg 2009; 35:1462-70
  5. Allergan Inc. Unpublished Data. CoolSculpting® Publications. INT-CSC-2050471. December 2020.
  6. Sasaki GH, et al. Aesthet Surg J 2014; 34:420–31
  7. Allergan. Unpublished data. INT-CSC-2050028. CoolSculpting® clinical “Fit and Function” study to test the V003 wells. February 2020.
  8. Allergan. Unpublished data. INT-CSC-2050288. Applicator cooling and distribution dye test. August 2020.EN-A.
  9. CoolSculpting® System (CoolSculpting® Elite) user manual. CS-UM-CM3-07-EN-E. Feb 2023.
  10. Manstein D et al. Lasers Surg Med 2008; 40: 595-604
  11. Avram MM and Harry RS. Lasers Surg Med 2009; 41:703-8
  12. Krueger N, et al. Clin Cosmet Investig Derm 2014; 7:201-25
  13. CoolSculpting® system user manual. BRZ-101-TUM-SGP-B COM1. Sep 2021
  14. FDA 501(K) Summary Document, Available at : http://www.accessdata.fda.gov/ [Accessed February 2022].
  15. Allergan, Unpublished date, INT-CSC-2050028, CoolSculpting, clinical fit and function study testing of V003 cups, February 2020.
  16. Spalding KL,et al. Nature 2008; 453:783-7.

Disclaimer: CoolSculpting is not a weight loss treatment.

SG-CSC-230058 Date of Approval: October 2023