2009 · Ulthera, Inc.
Ultherapy
Energy and depth. Microfocused ultrasound with imaging, 1.5 to 4.5 mm
Granted De Novo classification on September 11, 2009, to lift the eyebrow. Lax submental and neck tissue was added in 2012 and decolletage lines in 2014. Built-in imaging shows tissue to 8 mm.[1][2][3]
Suits. Mild to moderate laxity of the face, brow and neck. In a 35-subject study, 86% had a clinically significant brow lift at 90 days, with mean brow elevation of 1.7 mm. A meta-analysis of 42 studies found global aesthetic improvement in 89%.
Trade-offs. Moderate pain, a pooled mean of 4.85 out of 10. In 106 FDA device reports, lipoatrophy, nerve injury and scarring were reported most often.
2002 · Thermage, Inc.; Solta Medical from 2009
Thermage
Energy and depth. Monopolar radiofrequency with cryogen cooling, dermis
The ThermaCool TC was cleared for noninvasive treatment of periorbital wrinkles on November 5, 2002. The 2009 NXT and 2017 FLX systems are cleared for wrinkles and rhytids, including the upper and lower eyelids.[1][2][3]
Suits. Wrinkles around the eyes and lower face laxity. In an 86-subject study, 83.2% of treated periorbital areas improved by at least 1 wrinkle point and 61.5% of brows lifted at least 0.5 mm.
Trade-offs. Second-degree burns followed 0.36% of radiofrequency applications in that study, and 3 patients had small scars at 6 months. In over 600 treatments, 2.7% had temporary side effects.
2019 · Sofwave Medical
Sofwave
Energy and depth. Synchronous parallel ultrasound, mid-dermis at 1.5 mm
Cleared as the Sofacia System on September 9, 2019, for facial lines and wrinkles in people 22 and older. The 2021 SofWave clearance added eyebrow lift and lax submental and neck tissue. Parallel beams heat the dermis while a thermoelectric cooler protects the surface.[1][2][3]
Suits. Lines, wrinkles and mild laxity of the face and neck. In 36 participants, nasolabial fold and marionette line depressions decreased at 1 and 3 months. Biopsies to 10 months showed new collagen and elastin, with injury limited to the dermis.
Trade-offs. Mean pain scores were 5.6 and 6.64 out of 10 in two studies. Those clinical studies had 15 and 36 subjects.
2022 · Apyx Medical
Renuvion (J-Plasma)
Energy and depth. Helium plasma radiofrequency, epidermis or subcutaneous tissue
In March 2022 the FDA warned against using the device for dermal resurfacing and skin contraction. It then cleared the Dermal handpiece for wrinkles in Fitzpatrick skin types I to III on May 25, 2022, the APR handpiece for lax neck and submental skin on July 15, 2022, and post-liposuction use on April 27, 2023.[1][2][3]
Suits. Neck and submental laxity, and tissue after liposuction. In the APR neck study, 82.5% of 63 subjects were rated improved at day 180. In the Dermal study, 92.7% of 55 subjects improved by at least 1 wrinkle point at 90 days. One center reported 174 cases combined with high-definition liposuction.
Trade-offs. A 2025 review found 4 case reports of helium in the chest, abdomen or breast and FDA reports of 15 life-threatening events and 3 deaths. A 2026 meta-analysis of 3,508 patients pooled complication rates at 5% alone and 8% with liposuction.
2009 · Invasix, InMode
FaceTite and BodyTite
Energy and depth. Bipolar radiofrequency-assisted liposuction (RFAL), subcutaneous fat
Bipolar radiofrequency heats the fat and the underside of the skin during liposuction. Paul and Mulholland described the method in 2009. FaceTite is used on the face and neck and BodyTite on the body.[1][2][3]
Suits. Laxity with some fat. In a 12-patient split-abdomen trial, skin area shrank 25.8% with RFAL plus liposuction against 8.3% with liposuction alone at 1 year. Upper arm skin area shrank 33.5% at 1 year. In 80 neck patients, submental length fell an average of 23 mm at 6 months.
Trade-offs. In 247 lower face and neck patients, swelling over 6 weeks followed 4.8%, hardening over 12 weeks 3.2% and marginal mandibular neuropraxia 1.2%. A 2022 review found 77% of studies by authors with a known conflict of interest.
2009 · BTL Industries
Exilis
Energy and depth. Radiofrequency tissue heating
The Exilis Model 5000 was cleared on November 25, 2009, as an electrosurgical device. The Exilis XP and XP II labels cover tissue heating for temporary pain relief, muscle spasm and local circulation, and temporary reduction in the look of cellulite.[1][2][3]
Suits. The Aesthetic Society lists Exilis as a device that combines radiofrequency and ultrasound.
Trade-offs. The XP and XP II indications do not name wrinkles or skin laxity.
2017 · Cynosure
TempSure
Energy and depth. Monopolar radiofrequency with temperature feedback
Cleared on September 22, 2017. The 10, 15 and 20 mm Portrait handpieces are cleared for non-ablative treatment of mild to moderate facial wrinkles and rhytids. A thermistor in the handpiece tip reports skin temperature in real time.[1]
Suits. Mild to moderate facial wrinkles. In testing, handpiece temperature matched an infrared camera within 1.5 C.
Trade-offs. The larger 18, 25 and 30 mm handpieces are cleared only for tissue heating for pain, muscle spasm and circulation.