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 Allergan Inc. Unpublished Data.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