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Is Coolsculpting FDA Approved?

Is Coolsculpting FDA Approved?

Well-informed patients need to know the when, why and what of every medicine and procedure their doctor recommends. Coolsculpting is no different—peace of mind is vital when choosing a cosmetic procedure, even one as safe as coolsculpting.

Today, let’s go through the FDA’s approval of a typical ZELTIQ coolsculpting machine. Now, there are several varieties of coolsculpting machines in use, but all are held to the same standards.

In the beginning, ZELTIQ develops a machine they believe to be safer, faster, or otherwise superior to existing products. But to prove this new machine is safe and effective, the manufacturer typically funds a clinical trial, subject to approval of the FDA.

The FDA won’t just take ZELTIQ’s word for it, or glance over the machine’s technical specifications and sign off right away. Real data from real patients is needed.

If you feel like digging a little deeper, the full results can be found here.

The study focused on 60 people receiving abdominal coolsculpting using the ZELTIQ machine, and their results were evaluated 16 weeks after getting the procedure.

3 independent evaluators were asked to review the before and after pictures of the patients. 85% of the time, these evaluators chose correctly—meaning there was a clear improvement in 85% of the patients who underwent coolsculpting after one treatment.

The last bit is crucial, because some people may need 2 or 3 treatments to see the results they want. But 85% is a fantastic number.

Plus, patients backed up those evaluations with overwhelmingly positive opinion surveys, citing high satisfaction with the procedure. And beyond those surveys, ultrasound proved beyond a shadow of a doubt there was a significant reduction of fat in the targeted area.

Best of all, no patients reported any serious side effects.

These research studies are incredibly detailed. The FDA makes note of every bump, bruise and hiccup—nothing escapes its fine-toothed comb.

There is no 100%, totally safe procedure that works for every patient every single time. The FDA’s task is weighing drawbacks with benefits, and it found coolsculpting to be incredibly safe compared to invasive surgical procedures.

After collecting the data from the trial, the FDA holds an evaluation panel to either approve or deny the use of ZELTIQ’s machine. In many cases, the FDA holds drug or device manufacturers responsible for conducting post-approval studies after giving the green light.

That means ZELTIQ must be vigilant to ensure its coolsculpting patients remain healthy for the life of its product.

The FDA isn’t just approving every study or product in sight. It takes a lot of work to receive that coveted FDA approval stamp, and a vast majority of the time, the FDA panel is correct in their judgment.

Whether you’re coming in for coolsculpting on your stomach, thighs, or anywhere else, rest assured that our coolsculpting machines have been thoroughly vetted by the FDA for your safety.

You can count on it.

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