SculpSure is currently FDA approved for the abdomen and flanks (or love handles). However, it can and is being used in many other locations in what we refer to as "off-label" use. The company is in the process of expanding the FDA indications, and other areas will almost certainly be approved in the future. But it is safe to use, and definitely works in other locations as well.
Abdomen refers to the upper and lower abdomen itself, while the flanks are considered a separate treatment area. All parts of the thigh can be treated, but we are limited by the size of the applicators at any one time. the full thigh can be done, but it might take several sessions to cover the front, back, side...etc.
What areas can SculpSure treat?
SculpSure is FDA cleared to treat Abdomen and Flanks. But physicians can treat anywhere the applicator can be kept in complete contact with the skin.
FDA approved areas for sculpsure
Thanks for sharing your question. I can
appreciate your concern.
Your doctor is correct with the information that is provided. Although sculpsure is only approved to specific areas, this only means that the studies that have been approved by the FDA only have scientific data to the above mentioned areas. The company is in the process to provide with further data supporting the benefits in other areas. The fact that is not FDA approved for the other areas, does not mean that it can not be applied safely wherever there is fat.
Finally, make sure that you have a
consultation with a board certified plastic surgeon.
Wishing you the best in your journey
SculpSure uses a diode laser that targets and destroys subcutaneous fat cells. It is only FDA indicated for use in the abdomen and flanks, but "off label" use is common in basically any area of the body including the knees. The advantage of SculpSure over other techniques (CoolSculpting) is that it is quick, 25 minutes, and there are four 4" by 6" applicator heads that can be used separately or together. An area like the knee might need only one applicator head, so both knees can be treated at the same time! This also keeps the cost down by using only the number of heads needed.
SculpSure treatment areas
Thank you for your question. The SculpSure can be used to treat the abs,
flanks, upper arms, thighs, knees and other locations with fat deposits. Each
area must have an approved amount of fat deposit which is reviewed by the
doctor that you consult with. Make sure to research one that is well versed on the
Sculpsure, Coolsculpting, Vanquish
Sculpsure is a noninvasive 1060nm diode laser treatment that removes up to 25% of stubborn fat in the treated area in 25 minutes.It is FDA approved for the abdomen and flanks. It is safe if you get pregnant in the future.
The body contouring effects are seen in as quick as six weeks with final results at 12 weeks.
The results are permanent as long as you maintain your weight and health.
The laser targets and destroys the fat cells only which are then naturally removed from the body. Since the laser does not affect the skin or muscle it can be used on all skin colors and there has been no reported incidents of burns when treated by a properly trained physician. It is protective since it alternates heating and cooling.
It has four applicators that can be customized to treat the areas of stubborn fat.
If a second treatment is needed we wait at least six weeks and usually closer to 12.
There is no downtime and you can resume your normal activities right after the treatment. There may be some soreness in the area for a few days for which you can take ibuprofen or tylenol. A cold compress can also be used.
Sculpsure is not used for skin tightening however some of her patients have seen this. If more skin tightening is needed we have combined this with thermi or Ulthera for a complete treatment. Sculpsure is recommended for stubborn areas of fat that are not being lost by diet and exercise. It is not a weight loss treatment
Since I have both a coolsculpting and sculpsure I am working on protocols of utilizing both of these depending upon what areas need to be treated and the response to the treatment.
I have used sculpsure on other areas other than the abdomen with very good results.
I also use a Vectra 3D imaging system to try and show people what their treatment areas could look like.
Since Sculpsure outcomes can be based on technique and experience, please see a board certified plastic surgeon that specializes body contouring to see if Sculpsure or other treatments are available to meet your goals.
Board Certified Plastic Surgeon
Director-Beverly Hills Breast and Body Institute
Right now, SculpSure is only
FDA-cleared to treat the abdomen (stomach from rib cage down to pelvis area)
and love handles (also called flanks). However, many offices, including ours
are treating a wide array of other body parts, including the knees, thighs,
arms, bra/back fat, and even calves (anything below the sternum).
This is called an “Off
Label” treatment, and you might be surprised to learn this is accepted and
common practice in most cosmetic clinics. For example, Botox for crow’s feet
was not FDA-approved until about a year ago, but it was a commonplace treatment
because FDA approval is sometimes a long and expensive process, despite common
knowledge of safety and efficacy among physicians. FDA clearance (versus
approval) indicates the technology was previously in use and there is simply a
new application of that technology being cleared. The laser that powers
SculpSure is actually fairly old technology, and has a long history of safe use
in humans, which is why it is FDA-cleared (not approved). In terms of efficacy,
SculpSure works the best on soft, fluffy fat – the most common places we see
that kind of fat in women that are fit, like yourself, is at the top of the
inner thigh and the lower tummy “pouch.” However, SculpSure isn’t great at the
more fibrous fat, the kind that’s tough or looks flabby, not jiggly. But each
individual is different, so an in-person evaluation would render more precise
evaluation of what types of fat you have where.
From your photo, however, I
would note it appears your knees are experiencing normal aging for women,
wherein the skin loses some elasticity. You might be happier with a
skin-tightening treatment like Thermage or ThermiTight there.
Does Sculpsure only treat the abdomen and flanks
Sculpsure is FDA approved to treat the abdomen and flanks. Any other use is considered off label that means we treat a variety of area's but the machine is only FDA approved for the above area's. Abdomen means the upper and lower abdomen.
Sculpsure versus Hi Definition Knee Contouring
Sculpsure is approved for abdomen and flanks and not for thighs although we are using it for thighs, arms, and other areas. I find that the knees have a lot of fibrous fat that needs surgical removal especially when an energy based device like VASER or Laser. I suggest you see an expert. Best, DR. Emer.
Rules and regulations with SculpSure
Sculpsure is only approved by the FDA for the abdomen and flanks. In Australia, we advice our patients the same rules, however 'off label' use can be performed for arms, buttocks, thighs, etc..
Though successful in 'off label' areas, you will need to discuss with your Specialist the risk- benefit ratio of this performing SculpSure in these areas.
All the best
DR Davin Lm
Fiori Institute of Body Contouring