CoolSculpting Q&A
75%
WORTH IT RATING
"Worth It Rating" shows the % of consumer reviewers that stated the procedure was "Worth It" or not. See more RealSelf Worth It Ratings or Add Your Review
CoolSculptingbefore & after photos
View Before and Afters

Average CoolSculpting Cost: $1,525

Learn about CoolSculpting

870 people and 113 doctors are talking about CoolSculpting

Get Free Email Updates

Is Zeltiq Approved by the FDA for Fat Reduction?

asked 10 months ago by iloveplastic in ca
Latest answer by David Finkle, MD
Question viewed 671 times
Tags: fat reduction, FDA

has the FDA really approved Zeltiq for fat reduction?

10 answers to Is Zeltiq Approved by the FDA for Fat Reduction?

+2

FDA cleared CoolSculpting by Zeltiq for fat reduction works well

CoolSculpting by Zeltiq otherwise known as chilling fat for fat reduction is: In use and approved in the United States and more than 30 countries Was initially tested in 13 centers around the US for several years. Our site in Baltimore was one of the test sites. Fat layer reduction of 22% for love handles (flanks) was demonstrated in the study and was the basis for FDA clearance. Our site has seen great results typically exceeding 35% reduction of... more
+2

CoolSculpting by Zeltiq is FDA-Approved for fat layer reduction

CoolSculpting by Zeltiq is FDA-Approved for fat layer reduction in the United States. It is currently also available in more than 30 countries all over the world. The original 13-center study in the U.S. included, among others, Massachusetts General Hospital. The findings of all 13 centers revealed a significant fat layer reduction that, at minimum, ranged between 20% to 25% reduction, with a number of patients showing even greater reduction. Having performed over 1,000 treatments at our... more
+1

CoolSculpting clearance given by the FDA

CoolSculpting or "fat freezing" was FDA cleared in September of 2010 as a fat reduction device. After extensive testing on pigs and then in humans it is the first device to eliminate fat non surgically by using cold treatments. It is safe, effective, easy, with no down time and no need for anesthesia. Most sessions last 1-3 hours with the patients returning to normal activity immediately. We have people come in over their lunch hour for treatments, you can... more
+1

FDA and CoolSculpting

Thank you for your question. CoolSculpting by Zeltiq has been FDA cleared for fat reduction. Just so everyone understands, medications get FDA approval, medical devices (such as CoolSculpting machine) get FDA clearance. Best Wishes! see video
+1

Zeltiq Coolsculpting FDA approval

Technically, Coolsculpting is a medical device, so there is no "FDA approval" like prescription drugs. However, it does have FDA-clearance as a medical device for fat reduction since September 2010. So for most purposes, it is considered "approved." The clinical effectiveness of Coolsculpting is clear, and most importantly it is very safe as a non-invasive and non-surgical fat reduction treatment.
+1

CoolSculpting is FDA Cleared

CoolSculpting is cleared by the U.S. Food and Drug Administration (FDA) for the non-invasive reduction of fat. ZELTIQTM, a global medical device company, developed the procedure which delivers a non-invasive, safe, and clinically proven method for the selective reduction of “love handles” or flank.
+1

Is zeltiq approved by the FDA

Zeltiq was approved September of last year for localized fat reduction. It had been approved the year prior for "skin cooling" and it was during this time that the non-invaive fat reduction was proven through multiple clinical trials
+1

Zeltiq Coolsculpting is FDA approved

Coolsculpting is an FDA approved procedure for fat reduction in the love handle (flank areas). Over 50,000 patients have been treated to date.
+1

Zeltiq CoolSculpting FDA cleared for fat removal from Love Handles

The FDA clearance was given to Zeltiq CoolSculpting for body contouring for the flanks, love handles, but doctors can use it for off label areas such as the abdomen if the applicator fits the area well. This non surgical approach can reduce the fat volume of the treated area by 20% in four months time after one treatment, but results vary. Some patients have multiple treatments repeating them every few months. see video
+1

CoolSculpting by Zeltiq is FDA approved for fat removal

CoolSculpting by Zeltiq has been FDA approved for fat removal since September 2010. This procedure can remove fat without any surgery, incisions, needles, anesthesia, and requires no downtime. The procedure definitely works in the right patient and if you like you could look at the before and after photos which I have posted on RealSelf.

Ask a question