2010 · Zeltiq Aesthetics (now Allergan Aesthetics)
CoolSculpting (cryolipolysis)
Mechanism. Cold: controlled cooling of fat (cryolipolysis)
An applicator draws the fat bulge in by vacuum and cools it for about an hour. FDA classified the device for fat reduction in 2010, starting with the flanks. Clearances followed for the abdomen (2012), thighs (2014), submental area (2015), and bra fat, back fat and banana roll (2016), for people with a BMI of 30 or less.[1][2][3]
Suits. A localized bulge that remains despite diet and exercise. Across 30 studies with 3,158 participants, abdominal circumference fell a mean 3.56 cm and suprailiac fat thickness 5.22 mm at 12 weeks.
Trade-offs. Paradoxical adipose hyperplasia in 0.22% of patients in a 2025 meta-analysis. Numbness was reported in 49.5% of patients across studies. Not for people with cryoglobulinemia, cold urticaria or paroxysmal cold hemoglobinuria.
2015 · Cynosure
SculpSure
Mechanism. Heat: diode laser (1,064 nm in the FDA summary, 1,060 nm in published studies)
Laser energy heats the fat to 42 to 47 C while the skin surface is cooled. FDA cleared it on May 15, 2015 for non-invasive lipolysis of the flanks. A treatment lasts about 25 minutes.[1][2][3]
Suits. Fat bulges of the abdomen and flanks. In the FDA clearance study of 49 subjects, flank fat fell an average 13% on ultrasound 12 weeks after one treatment. In a 2017 study, fat volume on MRI fell 24% at 3 months.
Trade-offs. ASPS lists loose skin and fat deep to the abdominal muscles as reasons not to treat. Swelling, bruising, pain, blistering, redness and nodules occurred in the clearance study and resolved without treatment. 34 MAUDE reports from 2014 to 2020 concerned 1,060 nm laser lipolysis.
2012 · Cutera
truSculpt
Mechanism. Heat: monopolar radiofrequency at 1 and 2 MHz
First cleared in November 2012 for tissue heating and temporary reduction in the appearance of cellulite. In June 2018, FDA added non-invasive lipolysis and circumference reduction of the abdomen for the 2 MHz, 40 cm2 handpiece. In that clearance study, biopsies from 12 abdominoplasty patients showed peak fat cell death at 30 days, about 33% of fat cells.[1][2][3]
Suits. Abdomen and flanks. In a 12-patient study of truSculpt 3D, fat thickness fell a mean 4.6 mm (24%) at 12 weeks after one 60-minute session.
Trade-offs. Skin is heated to 44 to 45 C; pain scores in that study were 2 to 4 out of 10. In a MAUDE analysis, radiofrequency devices had the most reports (41.9%), most of them burns.
2014 · BTL Industries
Vanquish
Mechanism. Heat: contactless selective radiofrequency
The applicator heats fat from about 1 cm above the skin without touching it. A course is about 4 weekly sessions of 30 to 45 minutes. The Vanquish ME applicator covers 2,100 cm2. The year shown is the first published clinical study in the sources.[1][2][3]
Suits. Larger areas of abdominal and flank fat. In a 40-subject study, abdominal circumference fell an average 4.93 cm after 4 sessions. In a 36-subject comparison, abdominal fat thickness fell 4.17 mm (29.5%) with Vanquish ME. 13 patients kept 75.2% of their waist reduction at 4 years.
Trade-offs. Mild redness was the reported side effect. ASPS states abdominal results average just under 2 inches and not all patients have a measurable reduction. In the 2014 study, 3 of 35 subjects did not respond, the group with the thinnest fat.
2018 · BTL Industries
Emsculpt
Mechanism. Muscle: high-intensity focused electromagnetic field (HIFEM)
A magnetic field makes the muscle under the applicator contract. The usual protocol is 4 treatments over 2 to 4 weeks. Studies cover the abdomen, buttocks, thighs, arms and calves. The year shown is the first published MRI study in the sources.[1][2][3]
Suits. Abdominal and buttock muscle tone. In a 22-patient MRI study, fat thickness fell 18.6%, rectus abdominis thickness rose 15.4% and muscle separation narrowed 10.4% at 2 months.
Trade-offs. A 2023 systematic review of 14 studies found mean changes of 5.5 mm in fat and 2.2 mm in muscle, with almost all studies authored by medical advisors to the maker, and rated the efficacy evidence tenuous. No complications were reported in the studies reviewed.
2022 · BTL Industries
Emsculpt NEO
Mechanism. Heat and muscle: radiofrequency synchronized with HIFEM
One applicator delivers radiofrequency heating of the fat and HIFEM muscle contractions at the same time. The trial protocol was 3 abdominal treatments, once a week. The year shown is the first sham-controlled trial in the sources.[1][2][3]
Suits. In a 72-patient sham-controlled trial, abdominal fat thickness fell 28.3% (7.6 mm) and rectus abdominis thickness rose 24.2% at 3 months. The sham group showed no significant change.
Trade-offs. 2 of the 15 studies in a systematic review used Emsculpt NEO. A separate review found early muscle gains after electromagnetic treatment are consistent with swelling after exercise.
2021 · InMode
Evolve
Mechanism. Muscle and heat: electrical muscle stimulation (EMS) and radiofrequency
FDA cleared the Evolve System with the Tone applicator on March 5, 2021 and with the T3 (Transform) applicator on July 19, 2021. The T3 applicator works in RF mode and EMS-TENS mode.[1][2]
Suits. Cleared uses: EMS for muscle re-education, disuse atrophy and local circulation; RF heating for temporary relief of muscle aches and spasm.
Trade-offs. Both 510(k) summaries list clinical performance data as non-applicable; clearance rested on bench testing. Neither lists fat reduction as an indication.
2015 · Kythera Biopharmaceuticals (now an affiliate of Allergan)
Kybella
Mechanism. Injection: deoxycholic acid, a cytolytic drug
Injected into the fat under the chin at 0.2 mL per site, 1 cm apart, up to 50 injections (10 mL) per session and up to 6 sessions at least 1 month apart. FDA approved it on April 29, 2015. Use outside the submental area is not established.[1][2][3]
Suits. Moderate to severe fullness under the chin. In two phase 3 trials of 1,022 adults, a 1-grade improvement occurred in 70.0% and 66.5% of treated patients, against 18.6% and 22.2% on placebo. At year 3, 82.4% of followed responders kept the improvement.
Trade-offs. Swelling (87%), bruising (72%), pain (70%) and numbness (66%). Marginal mandibular nerve paresis in 4% resolved in a median 44 days. Most patients have at least 2 sessions.