Sofwave vs. Ultherapy: What's the Difference?

FDA's 510(k) summaries describe a system that generates high-frequency ultrasonic pulses that heat the dermis and create controlled, isolated areas of thermal damage. The handpiece holds an array of ultrasonic transducers and an active cooling element that cools the skin surface during treatment.

In the comparison table filed for Sofwave's 2022 cellulite clearance (K223237), FDA lists:

• energy type: "High Intensity non-focused" ultrasound;
• treatment depth: 1–2 mm;
• tissue temperature at the focal zone: 60–70 °C;
• epidermal impact: "Non-invasive; Cooling."

The company calls its approach SUPERB (Synchronous Ultrasound Parallel Beam) with integrated Sofcool cooling and says the energy is centered in the mid-dermis at 1.5 mm. For the full single-device guide, see What Is Sofwave?.

FDA's summary for the May 2026 clearance (K260618) says the Ulthera® System produces "controlled tissue coagulation below the skin surface" by delivering "highly focused, low-energy ultrasound" to discrete points in the first few millimeters of tissue. The heated points lead to contraction of the skin. The American Academy of Dermatology (AAD) puts it more simply: ultrasound sends heat deep into the skin, and that heat can prompt the body to make more collagen, so results build over months.

What sets Ultherapy apart in FDA's own comparison language is imaging. With the DeepSEE transducer, the clinician can visualize depths up to 8 mm. Cleared imaging uses are to confirm the transducer is properly coupled to the skin, confirm treatment depth and avoid bone. For the full single-device guide, see What Is Ultherapy?.

Both devices are cleared through FDA's 510(k) process (Ultherapy's category also began with a 2009 de novo grant). Clearance means substantial equivalence for the listed uses. It is not the same as FDA approval of a drug.

Sofwave (SofWave System) — ultrasound indications as listed in K250146 (Apr. 18, 2025):

• improve facial lines and wrinkles;
• lift the eyebrow;
• lift lax submental (beneath the chin) and neck tissue for adults 22 and older;
• short-term improvement in the appearance of cellulite;
• treatment of acne scars;
• improve the appearance of skin laxity on the upper arms.

Key clearances: K191421 (2019, facial lines/wrinkles); K211483 (2021, brow and submental/neck); K223237 (2022, cellulite); K233104 (2023, acne scars and upper-arm laxity, with K231537 in the predicate chain). Sofwave also has a separate Pure Impact electrical muscle-stimulation module (NGX); that module is outside this face/neck ultrasound comparison.

Ultherapy (Ulthera® System) — indications as listed in K260618 (May 21, 2026):

• lift the eyebrow;
• lift lax submental and neck tissue;
• improve lines and wrinkles of the décolleté;
• improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms, and knees.

Key milestones: de novo DEN080006 (2009); K121700 (2012, submental/neck); K132028 (2013, DeepSEE imaging); K134032 (2014, décolleté); K243035 (2025, abdomen/arms); K260618 (2026, knees).

Overlap, in plain terms: both are cleared for brow lifting and for lax tissue under the chin and on the neck. Sofwave's facial-wrinkle, cellulite, acne-scar and upper-arm wording, and Ultherapy's décolleté, abdomen, arm and knee wording, are where the indication lists diverge. Ask which cleared indication your clinician is treating.

When Sofwave first compared itself to Ultherapy in FDA's K191421 table, the depths listed were:

• Sofwave: 1–2 mm;
• Ultherapy: 4.5 mm, 3 mm and 1.5 mm (matching transducer labels such as 4-4.5, 7-3.0 and 10-1.5 in later Ultherapy records).

Sofwave's later table (K223237) keeps Sofwave at 1–2 mm and describes its energy as non-focused with cooling required. Ultherapy's imaging clearance lets the clinician see under the skin while treating. Those are mechanism differences in the filings — not a ranking of which depth is "better."

• Ultrasound tightening in general (AAD): with one ultrasound treatment, most people see modest lifting and tightening within 2 to 6 months; some people get more benefit from additional treatments. Non-invasive tightening leaves the skin intact and still cannot match a facelift, eyelid surgery or neck lift.
• Ultherapy brow study (Alam et al., JAAD 2010): in a prospective, rater-blinded cohort, 30 of 35 evaluated patients (86%) had a clinically significant brow lift at 90 days; mean brow elevation was 1.7 mm. Transient mild redness and swelling were reported.
• Sofwave company studies in 510(k) summaries: small manufacturer studies with about three months of follow-up supported each indication expansion (for example, facial lines/wrinkles in K191421; brow and neck in K211483). They show measurable but modest photo-based changes. They are not head-to-head trials against Ultherapy.

This guide does not claim one device lasts longer, lifts more or suits more people. Ask your clinician what evidence they rely on for your concern.

Both are non-invasive in the AAD sense: the skin surface is not cut or punctured.

• Sofwave: the manufacturer's providers FAQ says patients can resume daily activities immediately, with minimal post-treatment downtime. FDA summaries for Sofwave studies describe pain ranging from moderate (facial study mean score in the "moderate" range) to none/mild (upper-arm study), and expected short-lived redness or swelling in some protocols. The company's safety page lists possible adverse events including significant pain, tenderness, pigment changes, persistent redness and swelling, ulceration/erosion and/or bruising.
• Ultherapy: manufacturer marketing on ultherapy.com describes "zero downtime." The AAD's general guidance for non-invasive tightening lists temporary redness and swelling as the usual signs, with little or no downtime, and notes that some discomfort during treatment is possible.

Technique, settings and the area treated matter. Ask how discomfort is managed and what your first few days usually look like in that practice.

Might consider either (or a different option): adults whose concern matches a cleared indication and who want gradual, modest change without surgery. Overlap is strongest for brow, under-chin and neck laxity.

Sofwave-specific labeling (manufacturer safety page): treatment is contraindicated for open wounds or lesions, severe or cystic acne, or pacemakers/electronic implants in the treatment area. Precautions include pregnancy or recent childbirth/breastfeeding, active infection or skin disease, significant scarring, metal stents or facial implants, treating directly over dermal filler, isotretinoin or other retinoids in the past 6 months, and certain psychiatric, anti-platelet or anti-coagulant drugs in the past 2 weeks.

Ultherapy: it is a prescription device that delivers heat below the skin; candidacy is a clinical decision. Tell your clinician about implants, fillers, skin conditions, medications, and any open wound or active infection in the area.

Skin type: Sofwave's company materials say it is safe for all skin types; FDA's cleared indications do not address skin type. The AAD describes non-invasive ultrasound tightening as generally workable across skin colors. Discuss your skin and any pigment history with a dermatologist.

Neither replaces surgery. For the wider menu of options, see What Is Skin Tightening?. For how Ultherapy compares with RF microneedling, see Morpheus8 vs. Ultherapy and What Is RF Microneedling?.

• Which FDA-cleared indication matches my concern, and is my area on that device's list?
• Are you using Sofwave's ultrasound applicator, the Ulthera System with imaging, or something else?
• What depth or transducer plan do you use for my anatomy, and why?
• What results have you seen for someone with my skin type and degree of laxity — and over what time frame?
• How do you manage discomfort, and what downtime should I plan for?
• Do I have anything on a contraindication or precaution list (fillers, implants, recent retinoids, blood thinners, pregnancy)?
• Who performs the treatment, and who supervises it?

Featured doctors: Haute MD Network members include Dr. Jessica Weiser, a board-certified dermatologist and laser specialist and founder of Weiser Skin MD in SoHo, New York and Aspen, Colorado, whose practice offers collagen-stimulating treatments like Sofwave, and Dr. Lisa Airan, a board-certified cosmetic dermatologist in New York City whose practice includes skin-tightening technologies such as Thermage and EmFace. Browse Dermatology in Find a Doctor. Listed doctors are paid members of the Haute MD Network. Editorial selection, not a ranking.

Related

• What Is Sofwave?
• What Is Ultherapy?
• What Is Skin Tightening?
• Morpheus8 vs. Ultherapy
• What Is RF Microneedling?
• What Is Neck Lift Surgery?

• FDA 510(k) summaries, Sofwave Medical Ltd.: K191421, K211483, K223237, K233104, K250146; Pure Impact EMS filing K251746 (accessed Nov. 5, 2026)
• FDA 510(k) summaries / de novo, Ulthera System: DEN080006, K121700, K134032, K243035, K260618 (accessed Nov. 5, 2026)
• openFDA, Device 510(k) API, product code OHV and Sofwave/Ulthera applicant searches (data updated Oct. 26, 2026; accessed Nov. 5, 2026)
• 21 CFR §878.4590, focused ultrasound stimulator system for aesthetic use (cited in the FDA letters above)
• Sofwave Medical, Safety Information, Providers FAQ (manufacturer; accessed Nov. 5, 2026)
• Ultherapy / Ulthera, ultherapy.com (manufacturer; accessed Nov. 5, 2026)
• American Academy of Dermatology, Many ways to firm sagging skin (accessed Nov. 5, 2026)
• Alam M, et al. "Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study." J Am Acad Dermatol. 2010;62(2):262-269. PubMed 20115948

This guide is for general information and isn't medical advice. Talk with a board-certified physician about whether a treatment is right for you.