has the FDA really approved Zeltiq for fat reduction?
Is Zeltiq Approved by the FDA for Fat Reduction?
Doctor Answers (11)
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 fat for appropriate patients in hundreds of treatments
- We carefully monitor all treatments with physician supervision
- It is now one of the safest and most effective treatments that we offer
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 center, we find CoolSculpting by Zeltiq to be one of the most successful and safest cosmetic treatments that we offer nowadays to our patients. I hope this information was helpful. Dr. Bowes
Zeltiq approved by FDA
CoolSculpting was approved by the FDA in September 2010 for cold-assisted lipolysis in the flank area. It further received FDA clearance later on for cryolipolysis at the abdomen as well. It is a non-surgical procedure that delivers controlled cooling to an area that selectively causes death of fat cells (~20-25% per area per treatment). The dead fat cells are slowly eliminated by your body, therefore improving contour of the treated area with hardly any downtime.
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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 even eat your lunch while you have your treatment!
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.
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.
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.
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
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.
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.