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Is CoolSculpting Safe?

CoolSculpting FDA Clearance History


CoolSculpting, the number one non-invasive fat-reduction treatment*, is FDA-cleared to freeze the fat for nine different treatment areas. The non-surgical treatment was first FDA-cleared in 2010 for those pesky love handles, also known as flanks or a muffin top.


Not long after, in 2012, the treatment was cleared for a very popular area people want treated: the abdomen (also known as belly fat, pot belly, or post-baby bulge).


Fast forward to 2014, when CoolSculpting was cleared to treat thighs; allowing CoolSculpting practitioners to treat the inner thighs and outer thighs…hello thigh gap and good-bye saddle-bags!


In 2015—the dawn of the selfie era—CoolSculpting welcomed FDA-clearance for fat underneath the chin (also known as submental fat or the double-chin).


In 2016, CoolSculpting received some love for small areas of fat, getting simultaneous FDA-clearance for treatment of bra fat, back fat, and fat underneath the buttocks (coined “banana roll”). CoolSculpting’s most recent FDA-clearance is the first-of-its-kind: treatment of fat on the upper arms…bye-bye bat wings!


And in 2018, CoolSculpting received the FDA-clearance for the submandibular area or below the jawline!


What Does Non-Invasive Mean?


Non-invasive—unlike invasive surgical procedures such as liposuction—means that there are no needles and no surgery, and for CoolSculpting, it also means that there is little to no downtime.


CoolSculpting uses a technology called cryolipolysis, discovered by a group of Harvard scientists. These scientists determined that our fat cells are hypersensitive to cold…much more so than skin, nerves, or muscle.


Their research revealed that when using very specific cold temperatures in a controlled setting, freezing fat would induce cell death, and then the body would naturally clear the dead fat cells.


How the CoolSculpting treatment works:

  • Fat gets cooled to just above freezing

  • Within the fat cells, crystals form, and then the fat cells die

  • As fat cells die they collapse and a natural inflammatory process removes the dead cells through the lymphatic system

  • The natural inflammatory process can take up to four months after treatment to remove dead fat cells; resulting in fat layer reduction.

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