CoolSculpting: Q&A
Ask a Question
Why is Zeltiq Used for Fat Removal?
According to the FDA Website:
FDA INDICATION FOR USE: The Zeltiq System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort.
Why is Zeltiq System used for Fat removal when it is FDA approved for another purpose?
Tags:
18 Doctor Answers |
Asked by
ANNA BEE
in Germany and US
+2
Zeltiq Coolsculpting for fat reduction
The Zeltiq Coolsculpting device was FDA-approved for the use of fat layer reduction in September of 2010. The reason why coolsculpting or cryolipolysis works lies in the observation by dermatologists that cold exposure to the skin induces inflammation and destruction of fat cells. This is seen in cases of "popsicle panniculitis" when kids hold popsicles to the sides of their mouths, causing indentations in their inner cheeks. The beauty of Zeltiq's...
more
+2
Coolsculpting Has FDA Approval for Fat Reduction!
Hi,
Coolsculpting is exciting since it is the only device currently approved by the FDA for long lasting non-invasive fat reduction. The ultrasound studies have shown that each treatment of a given area reduces the fat by 22%! Treatments are additive so if you do a second treatment 2 months down the line you will see more of a dramatic result! The great thing is that it is painless, non-invasive, and patient satisfaction is very high.
Best,
Dr. Liu
more
+2
Zeltiq is Now FDA approved for fat reduction!
Zeltiq recently got FDA approval for permanent fat reduction! Good candidates for this procedure are those who are no more then 15 lbs from their ideal weight that have stubborn fat pockets that are resistant to diet and exercise. It is an effective non-surgical way to permanently reduce stubborn fat.
Dr. Grant Stevens
You might also like...
Real Stories
So Far Exactly What I Expected - Irmo, SC
Just had procedure today on both flanks. after reading tons of reviews on here I felt...
+2
Zeltiq has now been approved by FDA for fat layer reduction!!
Hi there-
This just happened today- very exciting news indeed...
The FDA, by its approval, has acknowledged that the procedure is safe and effective for completely non-invasive fat layer reduction.
+1
CoolSculpting FDA Approved for freezing and eliminating fat
CoolSculpting is the safe, non-invasive way to reduce fat in common trouble areas that tend to be diet and excercise resitant. Developed by Harvard scientists, the precisely controlled, FDA-cleared, patented procedure uses a cooling technology that targets subcutaneous fat cells by freezing them to the point of crystallization. Once crystallized, the cells are then eliminated from the body through the lymphatic system in a natural process. There is no damage to healthy tissue or skin cells....
more
+1
Coolsculpting uses
As a skin cooling device, the fat removal occurs because of this reason. When the skin is cooled, the fat cells actually die and are eliminated from the body causing a significant reduction in the amount of fat in the area treated.
see video
+1
CoolSculpting - Yes it's FDA Approved for Banishing the Bulge
CoolSculpting (originally branded Zeltiq) is FDA approved for fat reduction.
Many technologies start off FDA approved for one purpose and end up being used for something totally different - Just look at Botox, Latisse or Viagra! Botox was originally used for eye twitching, Latisse for glaucoma and Viagra was a heart medication.
Because CoolSculpting can safely lower the temperature of fat cells - while not harming skin cells - the procedure can injure the fat...
more
+1
Zeltiq CoolSculpting is FDA cleared for fat removal
Initially the Zeltiq device had an indication for chilling the skin but as the company performed testing and then provided data to the FDA , they were granted FDA clearance for an indication of fat removal in Sep. 2010.
see video
+1
FDA cleared for Fat Reduction
Thank you for your question.
Yes, Zeltiq Coolsculpting was recently FDA cleared for fat reduction!
Approved by the U.S Food and Drug Administration (FDA), CoolSculpting smoothly cools undesired fat cells in the body resulting in a painless, controlled eradication of fat cells. The CoolSculpting method is based on science performed by the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, Massachusetts. Research determined that fat cells are more...
more
+1
Zeltiq does not actually REMOVE fat
It may be semantics, but zeltiq actually intiates a process called "apoptosis" otherwise known as 'programmed cell death' that leads fat to ultimately break itself down. intially after the treatment, the fat is still completely viable. however, with time the fat cells will actually breakdown and be absorbed by the body. the fatty layer will become noticeably thinner.
+1
FDA clearance for CoolSculpting
This question has now been answered. The FDA, in September of 2010, gave clearance to CoolSculpting as a fat reducing device. Over 165,000 treatments worldwide have been given to patients without any significant problems. This is a wonderful, non-surgical method of reducing fat in unwanted areas and soon will be one of the most popular cosmetic treatments in the world!!
+1
Zeltiq - CoolSculpting is now FDA approved for fat reduction!
The CoolSculpting device enables us to selectively target and destroy fat cells in localized areas such as the abdomen and flanks by selectively cooling the fat cells in these areas. Ideal candidates are those who exercise, maintain a steady weight, but are still unable to reduce fat in these stubborn localized areas.
+1
Zeltiq is approved for fat reduction!
FDA has agreed that the studies using Zeltiq for fat reduction are compelling enough to grant approval. This only occurred in the last few months but by now the website should have been updated. Excellent question though. FDA approval is important however sometimes medical devices are used "off label" prior to getting the official nod. Prior to approval it is legal and ethical for the machine to be used by a qualified licensed physician as long as there...
more
+1
Zeltig coolscultping is used for fat removal
Zeltig's Coolsculpting is a recently approved new procedure using cryolipolysis to permanently get rid of fat in areas that are typically resistent to exercise and diet. It is used because it is a safe, effective approach to localized fat reduction.
+1
FDA has approved Zeltiq / Coolsculpting for Fat Reduction
When a device is FDA cleared for an indication, it can be used off label for other purposes. It had been used in other countries for Fat Reduction and so it was appropriate to be used in the US for that. A doctor can't use a drug or device for anything if it is cleared, only what is considered by peers or experts in the field to be appropriate and customary. Having said that, the Coolsculpting device is now cleared for the flanks for fat reduction, but it will...
more
+1
Zeltiq and many other devices and medications are used for non-FDA approved uses
Zeltiq and many other devices and medications are used for non-FDA approved uses. Physicians are allowed to use devices and medications for other uses, as long as they are approved by the FDA for something. The FDA deems that the product is also safe. The company that creates the device or drug however cannot market it for non-FDA approved uses, but physicians can.
+1
Off-Label use of Zeltiq
In the US 'off-label' use of devices and drugs is common. You are 100% correct that Zeltiq is only FDA approved as a skin cooling device, but now that it has proven that it can reduce the thickness of the fatty layer it will most likely be used for fat reduction as its primary purpose.
+1
Zeltiq and FDA
Zeltiq has been approved for the FDA for the specific application of skin cooling.
However, as an FDA approved medical device, physicians in the US are permitted to use Zeltiq in an 'off label' manner for cryolipolysis. Zeltiq has been safely used in an off-label manner for body contouring by clinics in the USA for a few years now.
There are a number of devices and drugs that are routinely used in an 'off label' manner. Botox, for example, was initially FDA approved for cosmetic use for...
more
Comments (0)