Coolsculpting Licensing Since It’s Noninvasive. Can Anyone Provide This Service?

Question

Since Zeltic coolsculpting is a non-invasive technology can the equipment only be used under the supervision of a medical doctor/physician/plastic surgeon or can any beautician/beauty treatment facility provide this service by purchasing a machine?

Paul Vitenas, Jr., MD · Answer

CoolSculpting which is registered by the FDA as a prescriptive device, requires that a physician be in some way involved. Essentially the way things work is that if a machine is going to be sold by Zeltiq they have to verify that the device will be under the supervision of a licensed physician in the state that the device is being sold. How the physician chooses to utilize the device within his or her practice is then restricted by local laws having to do with physician extenders. Have you ever been to a pharmacy and met with a nurse practitioner or physicians assistant to get a prescription instead of going to see your primary care physician directly? Generally for a non-physician to be able to deliver the treatment the non-physician needs to be under the supervision of a licensed physician. With regards to the delivery of the treatment itself not many physicians will actually do the treatment themselves but will rather delegate the delivery of treatment to other clinicians who have been specifically trained on the delivery of these types of services.

Mike Majmundar, MD · Answer

Anyone who has a physician who can order the machine can provide coolsculpting.  The physician doesn't have to be on site or even involved.  Be careful with places that do not have their aesthetic physician on site.  Ideally, having the procedure performed at a plastic surgery practice gives you the most value for your money.  They can tell you if you're an actual candidate for coolsculpting or if you would be a better candidate for liposuction, tummy tuck, or Smartlipo or Vaser Lipo.

Young R. Cho, MD, PhD · Answer

I was the first plastic surgeon in the Houston area to bring on Coolsculpting.  I would say with any device, there is a learning curve.  Both in terms of knowing what the limitations of the device is, and gaining experience if this is something that can be delegated within a physician practice.I have found in my own practice that when I delegated completely, the results were more inconsistent.  Today I am involved in every consult and draw out the treatment plan for every patient prior to their treatment.  I still do many of the treatments myself depending on my schedule, but I do have a team that supports me. I would be weary of going to place where you don't see a physician or where the surgeon is not an expert in body contouring.

Ron Shelton, MD · Answer

CoolSculpting feezes fat cells which kills them. The area of lipid abundancy is treated for one hour while our patients watch NetFlix or use their IPADs, kindles, iphones, or listen to music or watch TV. Over four months, the average patient derives 20% reduction of fat volume There can be significant fat volume loss with a few treatments. The success of this treatment is that it works better than Zerona, and without surgery can provide good results, especially if retreated every two months for 3 treatments compared to more aggressive SmartLipo, Vaser, Ultrasonic and tumescent liposuction.

Robert Whitfield, MD · Answer

The devices are sold top medical practices.Body
reshaping can be performed with a cannula that removes fat via liposuction or
with noninvasive technology like Cool Sculpting.  With Cool Sculpting there is no cannula
inserted into your body.  All treatments
are performed on the surface from the outside in using technology that freezes
the fat.  Don’t hesitate to give us a
call in Austin regarding a Body Reshaping Consult at the Upper Room.  On our Facebook Page there is an Interview I
recently did with KVUE, a local news station in Austin, that was picked by
affiliates around the United States, including Miami.  During the Interview we discussed the
technology of Cool Sculpting as well as it application process.

The
discomfort from treatment does resolve.  Taking over the counter tylenol
or naproxen resolves this in the majority of cases.  If you have swelling
that is persistent then a waist binder is helpful.

Michael Law, MD · Answer

CoolSculpting devices are sold exclusively to physicians. The CoolSculpting device is FDA approved for the elimination of fat. It is a class II medical device. It does not need to be performed by the physician. Practitioners in a physicians office receive thorough training and will be supervised by a physicians, physician assistants and nurse practitioners.

Daniel Shapiro, MD · Answer

Thank you for your question. CoolSculpting should only be performed by a licensed, certified physician. This will ensure the best and safest treatment.

Tom J. Pousti, MD · Answer

Thank you for your question.

	At this time, Zeltiq Corporation is selling this machine only to licensed physicians who have to undergo a training period for themselves as well as their staff.  There is a certification process and after this is completed, the physician and/or his/her staff can perform this procedure.   This way, they can ensure that the patients have the best possible outcome and follow up after the treatment.

Grace Liu, MD · Answer

Hi,

	Zeltiq, the manufacturers of Coolsculpting, will only sell to physicians who are willing to be compliant with training and monitoring of the treatment.  They recommend all physicians who own a machine to undergo several months of  certification process so that treatments and follow up with patients is consistent and regulated.  The company is to be applauded for its adherence to medical ethics for the benefit of the patients.

	 

	Best,

	Dr. Liu

Coolsculpting Licensing Since It’s Noninvasive. Can Anyone Provide This Service?

Answers (9)

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