What is SculpSure, and what is it cleared for?
SculpSure is a body contouring laser made by Cynosure. It sends 1060 nm light through the skin to warm the fat layer underneath until fat cells are damaged, while a cooled surface protects the skin itself.
The FDA cleared SculpSure in 2015 for the flanks, added the abdomen the same year, then the back, thighs and the submental area (under the chin) in later clearances. "Cleared" means the FDA reviewed it through the 510(k) process for a specific intended use: to affect the appearance of visible fat bulges in those areas. It is not cleared as a weight loss treatment, and it is not cleared for every part of the body.
| Area | FDA-cleared? | Cleared for |
|---|---|---|
| Abdomen | Yes | BMI of 30 or less |
| Flanks (love handles) | Yes | BMI of 30 or less |
| Back and bra line | Yes | BMI of 30 or less |
| Inner and outer thighs | Yes | BMI of 30 or less |
| Under the chin (submental) | Yes | BMI of 49 or less |
| Upper arms, chest | Not in the cleared indications | Ask about other options at your consultation |
That last row matters. Older marketing, including our own old pages, listed arms and chest. We now only recommend SculpSure for the areas it's cleared to treat. Want the science of how heat removes fat? Read how SculpSure body contouring works.
What happens during a SculpSure session?
There's no anesthesia, no incision and no special preparation beyond showing up in comfortable clothes. A typical visit looks like this:
- Mapping the area.We mark the pocket of fat you want to address and choose how many applicators to use. The device can run up to four flat applicators at once on the body.
- Fitting the applicators.The applicators sit in a frame held on with a soft belt. They don't use suction, so there's no pulling on the skin.
- About 25 minutes of treatment.The laser warms the fat layer while the surface cooling switches on and off. Most people feel deep warmth that builds, then tingling, then relief as the cooling kicks in. You can read or scroll your phone.
- Back to your day.Once the belt comes off you can drive, go back to work or run errands. The area may be tender, a little swollen or feel firm for a while.
When will I see SculpSure results?
The laser does its work in one sitting, but the visible change takes weeks. Damaged fat cells are broken down and cleared by your body's normal clean-up process, so the area slims gradually instead of overnight.
| When | What's typically happening |
|---|---|
| Day of treatment | Warmth and some redness; you leave the office as usual |
| Weeks 1–3 | Tenderness, swelling or firmness settles; nothing visible yet |
| Around week 6 | Many people notice the first change in how clothes fit |
| Around week 12 | The full effect of that treatment is usually visible |
How much change? In the studies behind SculpSure's clearance, a single treatment reduced the measured fat layer on the flanks and abdomen by about 2.6 mm on average at 12 weeks, and independent reviewers could tell before from after photos about 90 to 95 percent of the time. Body weight barely moved, which is the point: this is a shape change, not a scale change.
Because each session removes a portion of the fat in the area, our team commonly plans two sessions about six weeks apart for a more noticeable result. Your plan may be different.
Free, no-obligation consultation
Is there one area that won't budge?
Book a free SculpSure consultation. We'll tell you honestly whether it's the right tool, or whether a weight loss plan should come first.
Am I a good candidate for SculpSure?
SculpSure works best as a finishing tool. It removes a portion of fat in a defined area; it doesn't treat obesity, loose skin or cellulite. Here's how we think about fit at the consultation:
Usually a good fit
You're at or near your goal weight, your weight has been stable, and there's a pinchable pocket on your belly, flanks, back or thighs that hasn't changed with diet and exercise.
Better to wait
You still have a lot of weight to lose. Losing weight first is the better plan, and SculpSure can shape what's left once you're close to your goal.
Not the right tool
Your main concern is loose skin, stretch marks or cellulite, or the area you want treated isn't in SculpSure's cleared indications.
Needs a closer look
You're pregnant, have a skin condition, implant or recent surgery in the area, or take medications that affect your skin. Tell us; we'll review it before recommending anything.
The body areas are cleared for people with a BMI of 30 or less, and every client's health history is reviewed before treatment.
How SculpSure pairs with medical weight loss
Regal is a medical weight loss clinic first, which changes how we use SculpSure. Most people who ask about it fall into one of two groups.
You're still losing weight
If you have more than a few pounds to go, a medical weight loss program does far more for your health and your shape than any device. That means a medical evaluation, a nutrition plan, weekly coaching check-ins and, when it's clinically appropriate, GLP-1 medication. Once you're near your goal, the pockets that stubbornly hang on are where SculpSure fits.
You're already at your goal
You've done the work and one area won't budge. That's the textbook SculpSure case. Your coach can help you hold your weight steady while the results develop, which matters: the fat cells left in the area can still grow if you gain weight later.
Either way, you get one team and one plan, rather than a spa that treats the area and sends you home.
Book a SculpSure consultation near Dallas
SculpSure treatments are done in person at our Mesquite office (700 US-80), just east of Dallas. Your consultant confirms the location and time when you book. The consultation is free and can be done online, by phone or in person. We'll look at the area, check that it's within SculpSure's cleared uses, explain how many sessions make sense and walk you through pricing. Prefer to text? Send a message to (817) 223-5553, or request a time below.
Frequently asked questions
Is SculpSure FDA-approved?
SculpSure is FDA-cleared, which is the correct term for this kind of device. The FDA reviewed it through the 510(k) pathway and cleared it for non-invasive fat reduction of the abdomen, flanks, back, thighs and under the chin. Clearance applies to those specific uses, which is why we only recommend it for those areas.
Does SculpSure hurt?
Most people describe it as tolerable. You'll feel deep warmth that builds and then eases each time the cooling cycles on, sometimes with tingling or brief intense heat. There are no needles. Afterward the area can feel tender, swollen or firm for one to three weeks, which is the most common side effect.
Can I go back to work after SculpSure?
Yes. There's no anesthesia and no wound, so most people drive themselves and go straight back to work or errands. You might feel some tenderness when you bend or when clothing presses on the area. Ask your consultant before heavy workouts in the first few days if the area is sore.
How many SculpSure treatments will I need?
It depends on the size of the area and your goal. One treatment removes a portion of the fat in that spot, and the manufacturer notes that most people need a series. At Regal we commonly plan two sessions about six weeks apart, then reassess once the full result shows around 12 weeks after the last one.
Can men get SculpSure?
Yes. The clinical studies included men and women, and the clearance isn't limited by sex. Men most often ask about the flanks and lower abdomen. The same rules apply: you should be at or near a stable weight, with a defined pocket of fat in a cleared area.
Medically reviewed by
Eric Naifeh, FNP, PMHNP, DC
Medical Director at Regal Weight Loss. Reviews labs, evaluates patients and approves prescriptions across every Regal location. This page was reviewed for medical accuracy on November 2, 2026. It is general education, not medical advice: your provider decides what's right for you after an evaluation.
Sources
- FDA 510(k) K182741: Cynosure SculpSure, indications for use (abdomen, flanks, back, thighs, submental)
- FDA 510(k) K150230: Cynosure SculpSure, original clearance for non-invasive lipolysis of the flanks (2015)
- Katz B, Doherty S. Safety and efficacy of a noninvasive 1,060-nm diode laser for fat reduction of the flanks. Dermatol Surg 2018
- Bass LS, Doherty ST. Safety and efficacy of a non-invasive 1060 nm diode laser for fat reduction of the abdomen. J Drugs Dermatol 2018
- Cynosure: SculpSure product information (treatment time, results timeline, side effects)
