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Non-surgical fat reduction and body contouring devices

23 min read

This article deals with which change the methods described as "non-surgical fat reduction" aim at, what has been measured in the research, and how the results should be read. Procedures using devices and injections are assessed separately. Rather than recommending a method, the aim is to explain the difference between a reduction in fat tissue, a change in circumference and the appearance of the skin.

What is non-surgical fat reduction?

"Non-surgical fat reduction" does not describe a single substance or a procedure that works in one and the same way. Cooling, ultrasound, radiofrequency and low-level light are studied with different tissue effects; injection lipolysis, on the other hand, rests on giving a substance.1,2 The use of a common name does not show that these methods carry the same result or the same risk.1

Are fat tissue and the appearance of the skin the same target?

The thickness of the fat layer, the laxity of the skin and the appearance of cellulite are separate assessments.1,3 The United States Food and Drug Administration (FDA) explains that some energy applications may temporarily change circumference or the appearance of cellulite, and that some aim at tightening the skin.1 An improvement in the skin does not mean that a loss of fat tissue was measured to the same degree.3

Evidence relating to the appearance of the skin is the subject of the laser and energy devices article. What is examined here is the fat target. The same technology name appearing in two places does not allow a rate of improvement reported for the skin to be carried over to fat reduction.1,3

How are devices distinguished from injections?

Cryolipolysis uses controlled cooling. The FDA explains that the fat released from fat cells damaged by cold is cleared by the body's immune system, usually within 2 to 3 months.1 High-intensity focused ultrasound (HIFU) uses sound energy, and radiofrequency (RF) electrical energy that produces heat in the tissue.1 Low-level laser is assessed separately from light applications that heat the tissue.1

In injection lipolysis, a substance rather than device energy is involved; the effect of deoxycholic acid in disrupting the membrane of the fat cell has been studied in this context.2 The properties of a device and the effect, suitability and risks of an injected substance are therefore not the same questions.1,4 The word "melting" does not stand in for these different mechanisms.

Which changes are to be expected, and which are not?

Why is it not a method of losing weight?

The FDA states explicitly that non-invasive body contouring does not treat obesity, does not result in weight loss and does not stand in for the health benefits associated with losing weight.1 A change measured in one area does not mean that overall body weight or health changed to the same degree.1,3

A person losing weight during a study does not on its own show that the loss came from the device. In Garibyan's cryolipolysis study, weight was measured but its change was not controlled, and mean weight fell.5 In Falster's study, by contrast, weight change was used as an exclusion criterion.6 "Weight was monitored" and "the effect of weight was controlled for" therefore have to be kept apart.

What does a reduction in circumference measure?

A tape measure assesses body circumference, a caliper the skinfold held between the fingers, and ultrasound the fat layer in a particular area; volume calculated from a surface image is a further measurement.3,5 These are not outcomes that can be used in place of one another.3 One study reporting centimetres and another millimetres or volume does not mean the results can be converted to a common scale and the methods ranked.

The measurement review by Auh and colleagues states that circumference and caliper results can be affected by confounding factors, that ultrasound has limitations depending on the operator, and that appearance assessments can be subjective.3 These limitations do not make the measurements worthless; it is necessary to know which measurement answers which question.

The change in the control group also matters. A reduction in circumference in the treated group does not show that the whole of the reduction belongs to the procedure; change can also be seen in a group followed with an inactive device.7 A research average should not be read as the body measurement a person will reach.

What does the evidence on efficacy show?

Cryolipolysis

Garibyan and colleagues randomly selected the flank to be treated in 11 people and used the opposite flank as an internal control.5 At 2 months, the reduction in volume calculated from three-dimensional surface imaging was reported as 56.2 ± 25.6 mL on the treated side and 16.6 ± 17.6 mL on the opposite side (p<0.0001).5 This is not the volume of pure fat removed from the body and measured; it is a change calculated from an image.5

In the same research, the caliper measurement on the treated side fell from 45.6 ± 5.8 mm to 38.6 ± 4.6 mm, while no significant reduction was found on the opposite side (p<0.001 on the treated side).5 Different measurements thus gave a favourable finding in the same direction; the sample, however, is small, weight change was not controlled, and follow-up was limited to 2 months.5

In the assessor-blinded randomised study by Falster and colleagues, 38 women were allocated to groups and 34 completed the study; there were 17 people each in the treated and untreated control groups.6 Participants were asked not to change their diet or physical activity, anthropometric measurements were monitored, and a change of more than 5 per cent in baseline weight or body mass index was used as grounds for exclusion.6 No significant between-group difference was found in ultrasound, skinfold or either abdominal circumference measurement on day 30, 60 or 90.6

This study assessed only a single application; the authors separately discuss research examining repeated applications.6 The result cannot be generalised to every cryolipolysis regimen. At the same time, an unfavourable finding with weight control should be preserved alongside the small favourable study. The region, control and measurement design of the two studies differ; the difference between them cannot be attributed to weight alone.5,6

High-intensity focused ultrasound

The 180-person study by Jewell and colleagues compared two different energy levels with an inactive device.7 Weight was monitored and its change was taken into account in the statistical analysis.7 In the intention-to-treat analysis, which is based on the randomly assigned groups, the change in circumference at week 12 was reported as -2.06 cm and -2.44 cm in the active arms and -1.43 cm in the control.7 The difference from the control was not significant for the first active arm (p=0.13) and was significant for the second (p=0.014).7

In the analysis of participants who followed the protocol, changes of -2.10 cm and -2.52 cm were reported in the active arms and -1.21 cm in the control, and both active arms differed significantly from the control (p=0.04 and p=0.002 respectively).7 These two analyses do not say the same thing. If only the second is chosen, the non-significant result in the first becomes invisible.

The outcome measured is waist circumference; it is not fat volume measured by imaging, nor weight loss.7 Because a reduction was also found in the control, the total reduction in an active arm cannot be read as the difference attributed to the device. This research does not establish a common centimetre target for all ultrasound devices.

Radiofrequency

The review by Vale and colleagues included 12 studies; 9 of these were classified as pre-experimental and 3 as randomised designs.8 Different measurements such as fat and skin thickness, circumference and cellulite were examined, and the quantitative synthesis covered 14 variables from 5 studies.8 The authors reported that the clinical results were favourable in the direction of a reduction in fat tissue, but that the quality of the methods remained low.8

In the review's statistical analysis, it is stated that anthropometric measurements, one of the most commonly used means of assessment, produced questionable results.8 The methodological quality of the studies was assessed with the PEDro scale and none scored above 6 out of 10.8 Factors such as diet and physical activity not being adequately controlled is also among the problems this review points to.8 A single fat thickness or reduction in circumference belonging to all RF applications therefore cannot be derived from the results. Tightening of the skin, a change in circumference and thinning of the fat layer cannot be combined as the same outcome.1,8

Low-level laser

In the randomised study by Caruso-Davis and colleagues, 40 people were allocated to an active or an inactive device group and 39 completed the study.9 The same week-4 measurement of the same research gave a different result depending on who was included in the analysis.9

Included in the analysis Change in circumference, laser group Change in circumference, placebo group Between-group difference
The 31 people whose weight change stayed within 1.5 kg -0.78 ± 2.82 cm +1.35 ± 2.64 cm 2.15 cm; significant (p<0.05)
The 39 who completed, regardless of weight change -0.87 ± 2.65 cm +0.47 ± 3.19 cm 1.33 cm in the source; not significant

The values in the table are means and standard deviations; the differences are given as the source reports them.9 The 2.15 cm in the first row is not the laser group's own reduction in circumference. It is the difference between the reduction in that group and the increase in the control group.9 The 1.5 kg is the study's analysis criterion, not a weight limit given to the reader.

Participants were asked not to change their diet or exercise, and weight was monitored; even so, some people changed.9 Giving only the group whose weight changed little conceals the result for all participants; giving only the non-significant result leaves out the favourable finding in the selected group. The research measured circumference rather than imaging the fat layer, and this finding does not show how long the result is retained.9

Injection lipolysis

The review by Inocêncio and colleagues examining submental fat reduction with deoxycholic acid covers 5 randomised studies.2 Favourable results were reported for efficacy; the certainty of the evidence was assessed as low to moderate, and only 2 studies were found to be at low risk of bias.2 A potential industry bias was noted in all the studies; this does not in itself invalidate the finding, it is a limit on interpretation.2

In the study by Rzany and colleagues, in which 363 people were randomised, the co-primary outcomes are the response on the clinician's scale for the appearance of submental fat and the response on the scale assessing the person's satisfaction with their face and chin appearance.10 12 weeks after the final application, the proportion showing an improvement of at least 1 grade from baseline on the 5-point clinician scale was reported as 59.2 per cent and 65.3 per cent in the two active arms and 23.0 per cent in the placebo arm.10 On the 7-point SSRS, which assesses satisfaction with face and chin appearance, the proportion reaching a score of at least 4 was reported as 53.3 per cent and 66.1 per cent against 28.7 per cent.10 These are the shares meeting two different criteria, not a single overall success rate or values showing how many millimetres changed. The thickness measured with a caliper is a secondary outcome, and a significant reduction was reported.10

Stable weight, diet and exercise were required; a weight reduction programme was an exclusion criterion and weight was monitored.10 These measures do not mean that no participant's weight changed. These data for the area under the chin do not show the benefit of another substance or of an injection in another part of the body.2,11

How are authorisation and the suitability of the product assessed in Türkiye?

The physician's competence and the facility's authorisation

How health services for aesthetic and cosmetic purposes are to be provided in private outpatient diagnosis and treatment facilities is governed by the Regulation on Private Health Facilities Providing Outpatient Diagnosis and Treatment, dated 19 April 2025.12

The provision in force requires three conditions together. Health services for aesthetic or cosmetic purposes may be provided within a medical centre, a polyclinic or a doctor's practice; within the competences physicians have acquired through their training curriculum or through a certificate; within the medical procedures permitted at the facility where they work; and provided that the physical space and minimum medical equipment defined for a polyclinic room are in place.12

The certificate referred to in the regulation is one registered under Ministry legislation.12

The physician's competence and the facility's authorisation are separate things and both are required.12 A diploma alone, or any course certificate alone, does not show that all of these conditions are met. Nor is a training centre's authorisation to provide training the same thing as a physician's authorisation to carry out the procedure.12,13

This provision covers private outpatient diagnosis and treatment facilities. A complete list of authorisation by profession and title, for every type of institution, cannot be derived from this text.12

There is no heading for fat reduction or body contouring in the Ministry's Standard for the Certified Training Programme in Aesthetic and Cosmetic Applications dated 3 September 2025.13 That is an observation concerning only the content of that standard; it does not give the conclusion that the procedure is prohibited in every institution or that any course certificate is sufficient. The conditions in the legislation for the physician's competence and for the procedures permitted at the facility are assessed together.12

Is the legislation the same for a device and for an injected substance?

Article 5(5) of the Communiqué of the Turkish Medicines and Medical Devices Agency dated 14 March 2024 concerns equipment used, within the scope set out in Annex V, for the purpose of reducing, removing or breaking down fat tissue.14 The scope depends on the intended purpose and on the conditions of the relevant annex; it cannot be concluded from the name of a technology alone that all devices fall under the same provision.14

That provision governs equipment; it does not on its own explain the licence and area of use of an injected substance.14 The FDA's approval of deoxycholic acid for the area under the chin likewise relates to the United States and to a particular use; it does not take the place of a physician's or a facility's authorisation in Türkiye.11,12 Which legislation a product falls under has to be asked separately from who may apply it and in which facility.

The Ministry of Health's Product Tracking System (ÜTS) is a system for the registration and traceability of medical devices and cosmetic products.15 A product's registration information does not take the place of a physician's competence or a facility's authorisation. The traceability of a product and the benefit and risk expected in a particular person are also separate assessments.

The United States Food and Drug Administration (FDA) explains that registration or listing information is not the same as approval or marketing authorisation.16

It therefore has to be understood which registration the word "registered" refers to, and which product, area and intended use the word "approved" describes.1,16 These questions cannot be answered in place of one another.

What are the risks and unwanted effects?

Local effects and tissue injury

The FDA states that effects such as pain, redness, swelling and bruising have been reported after body contouring procedures carried out with devices.1 Although many local effects are temporary, burns related to cold or heat, changes in colour, tissue damage that may be permanent and, with some methods, nerve injury have also been reported.1 The list of risks and their frequency are not the same for every method.1

In the HIFU study, almost all of the bruising and oedema was reported as mild or moderate; there were also participants who experienced severe pain during the procedure.7 That balance requires neither seeing every procedure as carrying the same risk by looking only at severe cases, nor excluding serious problems by counting only temporary effects.

Cold sensitivity disorders and impaired circulation in the treated area matter in assessment for cryolipolysis.1 The FDA also states that there have been reports of hernia in the treated area after a cooling procedure, and that the procedure should not be performed over or near the area of an existing hernia or structurally weak areas, such as surgical scars or the separation between the abdominal muscles commonly seen after pregnancy.1 Conditions such as active electronic implants, metal, light sensitivity or a wound in the treatment area are assessed according to the technology concerned; none of them can be turned into a single list for every method.1

Paradoxical adipose hyperplasia

Paradoxical adipose hyperplasia (PAH) is the growth, rather than the shrinking, of fat tissue in the cooled area.1 The FDA explains that it is a raised, often rectangular, very firm mass of fatty tissue that usually takes the shape of the treatment applicator; that this problem is unique to the cooling method; that the reported cases developed 2 to 5 months after the procedure; and that it does not go away on its own and may require surgery.1 A hardness that grows later should not be assessed as ordinary early swelling alone.1

In the review by Mah and colleagues there are 29 cases of PAH among 13,078 people in 28 studies.17 The pooled estimate was reported as 0.22 per cent with a 95 per cent confidence interval of 0.10 to 0.47; the authors' plain equivalent is approximately 1 in 455 people.17 This is a research estimate with people as the denominator; it is not a risk per procedure or the probability any one person will face.

The certainty of the evidence was assessed as low, and it was stated that only 4 studies had at least 16 weeks of follow-up.17 Short follow-up can make it harder to count a problem that is noticed late in full.17 Statistical heterogeneity between the studies being low does not remove that limit on follow-up.17

Risks specific to injection

In the Inocêncio review, deoxycholic acid was associated with an increased risk of fibrosis, pain, erythema, numbness, swelling, oedema, itching, nodules, headache and paraesthesia compared with placebo.2 In the Rzany study, most local reactions were reported to be transient; that finding does not mean every late or lasting problem has been excluded.10

The FDA's warning of 20 December 2023 describes reports of permanent scars, serious infections, skin deformity, cysts and deep painful knots after unapproved fat reduction injections.4 The warning also addresses products sold online and practitioners who may not hold the appropriate authorisation.4 That context is not the same safety data as controlled research on an approved substance.

The FDA communication of 15 September 2026 reports 129 adverse event reports since 2015 relating to uses of deoxycholic acid outside the approved submental area.11 With use around the eye, blurred or reduced vision, muscle and nerve injury, facial paresis and paraesthesia have been reported.11 129 is not a denominator containing the number of everyone treated; a frequency cannot be calculated from it.

The same communication states that injection-site nodules and masses have also been reported with the approved submental use, that these may not resolve over time and that they may require medical intervention.11 Approved use and being free of risk are therefore not the same thing. A complaint such as a change in vision or a disturbance of facial movement should not be waited out as an ordinary local reaction.11

How is the duration of the result assessed?

Does a follow-up period mean permanence?

A study having measured at 4 weeks, 2 months or 12 weeks does not show that the effect ended on that date; nor does it show that it stayed the same for longer.5,7,9 These dates are the research's assessment points, not an individual result or a repeat schedule.

The FDA states that the results of non-invasive body contouring may be temporary and that not everyone achieves the effect they expect.1 That explanation does not mean that every result of every method disappears within the same period. Without knowing which method, area and measurement was followed, a single duration of persistence cannot be established.1,3

Nor does showing a mechanism that damages the fat cell prove that the long-term appearance will not change.1 A favourable finding in a study with short follow-up and a result retained over years are separate pieces of evidence. In research where weight change can affect a circumference measurement, how weight was monitored also matters when a long-term interpretation is made.5,9

How does this differ from liposuction?

The FDA explains that non-invasive body contouring devices do not remove tissue through a surgical incision.1 Surgical and laser-assisted liposuction are dealt with in the liposuction article. The technique of the operation and its recovery timetable are not used here as a measure of comparison.

Garibyan's control is the person's opposite flank, Falster's an untreated group, Jewell's and Caruso-Davis's an inactive device, and Rzany's an injection placebo.5-7,9,10 These studies do not show equivalence with liposuction. A favourable result being found is not enough to say that a separate method produced the same amount of change or change of the same duration.

Conversely, it does not follow from the limited changes in these studies that all non-surgical methods are useless. In controlled research, benefit was reported on some measures and no significant difference on others.6,7,10 What the comparison was made against determines the meaning of the word "effective"; a claim of the same result as surgery would have to be tested separately.

How should marketing language be read?

The words "fat melting", "approved" and "permanent"

The phrase "fat melting" does not say that fat is removed by the same route in every method. The cell culture experiments in the low-level laser study do not on their own prove by which route fat is removed in a person, or for how long it is reduced.9 An explanation such as "the fat is passed in the urine" is not the result that experiment showed.9

Nor should a reduction in one measurement be turned into a promise of the centimetres a person will obtain. That the 2.15 cm in the laser study is the difference between a selected group and placebo shows how a single figure changes when taken out of its context.9 A significant result here does not mean the same amount of change in everyone.

The authors of the Mah review state that the frequency of PAH appears to be higher than manufacturer reports.17 That conclusion is a reminder that a statement of risk in a product presentation alone is not sufficient; the review's low certainty and its problems with follow-up should stay alongside it. Putting another firm personal risk in place of a marketing estimate is not the solution.

The FDA explains that the safety and effectiveness of fat freezing offered for home or over-the-counter use has not been established.1 The word "non-surgical" is not a guarantee that makes medical assessment unnecessary.1 Product registration, approval of a particular use and benefit shown by research are separate pieces of information.1,16

How should the figures in this article be read?

Volume, thickness, circumference and an appearance scale are not the same measure. The sources using different measurement tools does not allow a ranking of methods to be established by adding the figures or by comparing their sizes side by side.3 Nor is a research average a value that predicts a person's own result.

The ± values in the laser table show the standard deviation, while the interval given for PAH shows the 95 per cent confidence interval of the pooled estimate.9,17 These are not the same kind of uncertainty. Garibyan's ± values are reported as the source gives them; they are not read as a range of results to be given to a person.5

The denominator of the PAH estimate is people, while the FDA's figure of 129 is a number of reports.11,17 They are not two values of the same risk calculation. In efficacy research, too, a change in who is included in the analysis can change the result.7,9 Every figure should therefore be assessed together with who was followed, what was measured, which control was used and how weight change was handled.

References

  1. U.S. Food and Drug Administration. Non-Invasive Body Contouring Technologies. FDA page. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13 ↩14 ↩15 ↩16 ↩17 ↩18 ↩19 ↩20 ↩21 ↩22 ↩23 ↩24 ↩25 ↩26 ↩27 ↩28 ↩29

  2. Inocêncio GSG, Meneses-Santos D, Costa MDMA, et al. Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction - A systematic review and meta-analysis of randomized clinical trials. Clinics (Sao Paulo). 2023;78:100220. doi:10.1016/j.clinsp.2023.100220. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  3. Auh SL, Iyengar S, Weil A, et al. Quantification of noninvasive fat reduction: A systematic review. Lasers Surg Med. 2018;50(2):96-110. doi:10.1002/lsm.22761. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9

  4. U.S. Food and Drug Administration. Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful. 20 December 2023. FDA page. ↩ ↩2 ↩3

  5. Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014;46(2):75-80. doi:10.1002/lsm.22207. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12

  6. Falster M, Schardong J, Santos DPD, et al. Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial. Braz J Phys Ther. 2020;24(5):441-448. doi:10.1016/j.bjpt.2019.07.005. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8

  7. Jewell ML, Baxter RA, Cox SE, et al. Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting. Plast Reconstr Surg. 2011;128(1):253-262. doi:10.1097/PRS.0b013e3182174278. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12

  8. Vale AL, Pereira AS, Morais A, et al. Effects of radiofrequency on adipose tissue: A systematic review with meta-analysis. J Cosmet Dermatol. 2018;17(5):703-711. doi:10.1111/jocd.12776. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  9. Caruso-Davis MK, Guillot TS, Podichetty VK, et al. Efficacy of low-level laser therapy for body contouring and spot fat reduction. Obes Surg. 2011;21(6):722-729. doi:10.1007/s11695-010-0126-y. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13 ↩14

  10. Rzany B, Griffiths T, Walker P, Lippert S, McDiarmid J, Havlickova B. Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study. Br J Dermatol. 2014;170(2):445-453. doi:10.1111/bjd.12695. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8

  11. U.S. Food and Drug Administration. Labelling warning on adverse reactions associated with the unapproved use of deoxycholic acid injection [title given by subject, without the brand name]. FDA Drug Safety Communication. 15 September 2026. Official communication. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  12. Republic of Türkiye Ministry of Health. Regulation on Private Health Facilities Providing Outpatient Diagnosis and Treatment. Official Gazette, 19 April 2025, no. 32875. Articles 4(1)(j) and 6(10). saglik.gov.tr ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8

  13. Republic of Türkiye Ministry of Health. Standard for the Certified Training Programme in Aesthetic and Cosmetic Applications. 3 September 2025. saglik.gov.tr ↩ ↩2

  14. Turkish Medicines and Medical Devices Agency. Communiqué on the Determination of Common Specifications for the Groups of Products Without an Intended Medical Purpose Listed in Annex XVI of the Medical Device Regulation. Official Gazette, 14 March 2024, no. 32489. Article 5(5). resmigazete.gov.tr ↩ ↩2 ↩3

  15. Republic of Türkiye Ministry of Health. The Product Tracking System has come into operation. saglik.gov.tr ↩

  16. U.S. Food and Drug Administration. Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved? fda.gov ↩ ↩2 ↩3

  17. Mah AE, Razeghi P, Li C, et al. Incidence of Paradoxical Adipose Hyperplasia After Cryolipolysis: A Systematic Review and Meta-Analysis. Aesthet Surg J Open Forum. 2025;7:ojaf142. doi:10.1093/asjof/ojaf142. ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8

The content on these pages is general information and does not replace individual medical advice. For decisions about your own situation, consult the physician who examines you.