Key takeaways
- Both devices are FDA-cleared, not FDA-approved, and both are cleared to lift the eyebrow and lax under-chin and neck tissue.
- Both are described treating at 1.5 mm; only Ultherapy lists deeper 3.0 and 4.5 mm transducers.
- Our research found no head-to-head trial, so nothing proves one device better than the other.
- Duration claims come from the makers, and no verified national average price exists for either device.
How do Sofwave and Ultherapy differ in depth and technology?
Sofwave and Ultherapy are both non-invasive ultrasound devices, and both are FDA-cleared rather than FDA-approved.
Sofwave (the SofWave System, from Sofwave Medical Ltd. in Israel) was first cleared in 2019 under the name "Sofacia System" for improving facial lines and wrinkles, and its latest clearance (K250146, dated 18 Apr 2025) covers improving facial lines and wrinkles, lifting the eyebrow, and lifting lax submental (under-chin) and neck tissue in people aged 22 and older, plus short-term improvement in the appearance of cellulite, acne scars and upper-arm skin laxity.
Ultherapy (the Ulthera System, from Ulthera, Inc., part of Merz) was first authorized in 2009 through FDA's De Novo pathway, and its current 510(k) clearance (K260618, dated 21 May 2026) covers lifting the eyebrow, lifting lax submental and neck tissue, improving lines and wrinkles of the décolleté, and improving skin laxity on the abdomen, front and back of the arms, and knees.
On paper the cleared uses overlap on the brow and under the chin, and each device adds areas the other does not list.
Sofwave cleared uses
- Lift the eyebrow
- Lift lax submental and neck tissue
- Facial lines and wrinkles
- Short-term cellulite, acne-scar and upper-arm improvement
Ultherapy cleared uses
- Lift the eyebrow
- Lift lax submental and neck tissue
- Décolleté lines and wrinkles
- Skin laxity on the abdomen, front and back of the arms, and knees
The technology differs too.
FDA's 510(k) summary describes the Sofwave applicator as an array of ultrasonic transducers emitting at 10–12 MHz with an active cooling element, heating the dermis to create controlled, isolated areas of thermal damage.
Sofwave says its SUPERB technology uses 7 parallel beam transducers and localizes the thermal effect between 0.5 and 2 mm deep, centered at 1.5 mm in the mid-dermis, heating tissue to about 60–70°C — that description is the company's, not the FDA's.
Ultherapy is micro-focused ultrasound, and its clearance includes the DeepSEE transducer, real-time ultrasound imaging that visualizes tissue up to 8 mm below the skin surface to confirm coupling and treatment depth.
The treatment depths the two sources describe overlap at 1.5 mm.
Ulthera's instructions for use (IFU) lists treatment depths as probe-dependent: its transducers treat at fixed depths of 1.5 mm, 3.0 mm or 4.5 mm.
Sofwave's maker places its thermal effect between 0.5 and 2 mm, centered at 1.5 mm in the mid-dermis — so both are described treating at 1.5 mm, only Ultherapy lists deeper 3.0 and 4.5 mm transducers, and no head-to-head trial in our research tests what that difference means for results.
| Sofwave | Ultherapy | |
|---|---|---|
| Energy | Parallel-beam ultrasound at 10–12 MHz (FDA's summary) | Micro-focused ultrasound (FDA documents) |
| Depth | 0.5–2 mm, centered at 1.5 mm (Sofwave's description) | Fixed depths of 1.5, 3.0 or 4.5 mm, set by the transducer (Ulthera IFU); imaging to 8 mm |
| Session | Typically 30–45 minutes (Sofwave's site) | Single session (Merz); Merz's FAQ says about 30 to 90 minutes depending on the area |
| First US authorization | 2019 (K191421, as "Sofacia System") | 2009 (De Novo DEN080006) |
Is Sofwave or Ultherapy more painful?
There is no head-to-head pain comparison of the two devices in our research, so the honest answer is that the sources describe each device separately.
Sofwave's safety information lists significant pain and tenderness among the potential adverse events of its ultrasound treatment, alongside changes in skin pigmentation, persistent redness and swelling, ulceration or erosion, and bruising — and it gives no rates for any of them.
For comfort during treatment, FDA's device summary describes Sofwave's applicator as having an active cooling element that cools the skin area in contact with it.
Merz's FAQ says an Ultherapy session takes about 30 to 90 minutes depending on the area treated, and that patients may feel heat and/or tingling.
Merz, Ultherapy's maker, says the most common side effects reported in its clinical trials were redness, swelling, pain and transient nerve effects.
In the face and neck trials described in Ulthera's labeling, those side effects were mild and transient: redness usually resolving within hours, swelling within 3 to 72 hours, welting within a week, bruising and tenderness within 2 days to 2 weeks, and transient muscle weakness or numbness from nerve inflammation typically resolving in 2 to 6 weeks — and no permanent facial nerve injuries were reported in those trials.
Ultherapy face and neck trials: how long side effects lasted
| Side effect | Typically resolved within |
|---|---|
| Redness | Hours |
| Swelling | 3 to 72 hours |
| Welting | A week |
| Bruising and tenderness | 2 days to 2 weeks |
| Muscle weakness or numbness | 2 to 6 weeks |
Merz markets Ultherapy as having zero downtime; that is the company's marketing wording, and the same company's labeling reports pain, redness and swelling in its trials.
Sofwave lists significant pain, tenderness, skin pigment changes, persistent redness and swelling, ulceration/erosion and bruising as potential adverse events, with no rates given. Ulthera's IFU warns that burns — which may or may not cause permanent scarring — can occur with incorrect technique, and the post-market reports it lists include burns or blisters, nodules, fat or volume loss, skin sagging or asymmetry, pigment change, scarring, numbness, muscle weakness, speech difficulty and vision changes; nerve effects lasting months have been described, and their frequency cannot be reliably estimated from those reports. Merz says the most common side effects in its clinical trials were redness, swelling, pain and transient nerve effects. Ask any provider you consult for each device's current safety information.
How long do Sofwave and Ultherapy results last?
Duration claims here come from the manufacturers — and from the cleared word "short-term" for Sofwave's cellulite, acne-scar and upper-arm uses — not from a trial that tested one device against the other.
Merz says Ultherapy PRIME is a single-session treatment and that its results "can last up to 6 months for the abdomen and arms and a year or more in the face." Merz also says most patients see results after one Ultherapy PRIME session, with some initial lift and final results developing over 2 to 3 months.
We did not find a comparable Sofwave duration figure in the sources we checked; Sofwave's cleared wording describes its cellulite, acne-scar and upper-arm improvements as short-term, and our sources give no Sofwave duration figure for the face.
Sofwave's own before-and-after gallery shows photos taken at widely varying times after treatment, from 4–6 weeks out to 10 months, some labeled with treatment counts such as "After 2 treatments" — so treat gallery images as the company's marketing and compare photos only at similar time points and treatment counts.
Whichever figure you read, it is an average or a maker's claim, never a promise of the result you will get.
How much do Sofwave and Ultherapy cost?
We could not verify a national average price for either device: ASPS's 2025 statistics release reports no minimally invasive procedure counts or fees, so there is no current ASPS average fee for Sofwave, and our research turned up no verified national figure for Ultherapy either.
What we can describe is the pricing structure, because that is what quotes are built on.
- Both companies describe a single treatment session — Merz for Ultherapy PRIME, and Sofwave for its typically 30–45-minute session.
- Session count is a main price driver for these energy treatments, and Sofwave's own gallery labels some results "After 2 treatments," so more than one session is possible.
- Ultherapy's cleared uses span the face and body areas from the abdomen to the knees, so ask exactly which areas a quote covers.
Ask each practice what its quote includes — device, area, number of sessions, any numbing or follow-up — and get more than one quote so you are comparing like with like.
Which should you choose, Sofwave or Ultherapy?
Because our research found no head-to-head trial comparing the two devices, nothing we found proves one better than the other.
What you can compare is each device's cleared uses: both lift the eyebrow and lax submental and neck tissue, Sofwave adds facial lines and wrinkles plus short-term cellulite, acne-scar and upper-arm improvement, and Ultherapy adds décolleté lines and wrinkles and skin laxity on the abdomen, arms and knees.
Candidacy is device-specific: Sofwave's safety information lists contraindications including pregnancy or breastfeeding (or giving birth less than 3 months ago), pacemakers or electronic implants in the area, metal stents or implants in the face, open wounds, severe or cystic acne, active infection, isotretinoin or other retinoids within the past 6 months, and anti-platelet, anti-coagulant or psychiatric drugs within the past 2 weeks, and it says treatment directly over dermal filler is not recommended.
On skin types, Sofwave's patient page says the device is "FDA-cleared to treat all skin types," but the FDA-cleared indications text does not mention skin types at all — read that as Sofwave's own claim, not an FDA statement.
A licensed provider who offers either device can examine the area you want treated, check it against that device's cleared uses and safety information, and tell you what the evidence does and does not cover — that conversation, not this page, is where the decision belongs.
- Which of this device's cleared uses covers the area I want treated?
- How many sessions does the quote include, and what would a second session cost?
- What does the device's safety information say about my medications and medical history?
- What side effects has this practice seen with this device?
Frequently asked questions
Is Sofwave or Ultherapy better?
We found no head-to-head clinical trial comparing the two devices, so nothing in our research proves one better than the other.
Both carry FDA clearances to lift the eyebrow and lax submental and neck tissue.
Sofwave's clearance adds facial lines and wrinkles plus short-term cellulite, acne-scar and upper-arm improvement, while Ultherapy's adds décolleté lines and wrinkles and skin laxity on the abdomen, arms and knees.
A licensed provider can match the cleared uses to the area you want treated.
Which goes deeper, Sofwave or Ultherapy?
By the descriptions we could verify, both treat at 1.5 mm, and only Ultherapy lists deeper 3.0 and 4.5 mm transducers.
FDA's documents describe Sofwave as parallel-beam ultrasound, and Sofwave's own description places its thermal effect 0.5 to 2 mm deep, centered at 1.5 mm in the mid-dermis.
Ulthera's instructions for use (IFU) lists treatment depths as probe-dependent — its transducers treat at fixed depths of 1.5 mm, 3.0 mm or 4.5 mm — and the DeepSEE imaging visualizes up to 8 mm below the skin.
No head-to-head trial in our research tests what that depth difference means for results.
How much does Sofwave cost compared with Ultherapy?
We could not verify a national average price for either device: ASPS's 2025 statistics release reports no minimally invasive procedure counts or fees, so no current ASPS average fee exists for Sofwave, and we found no verified national figure for Ultherapy.
Merz describes Ultherapy PRIME as a single-session treatment and Sofwave's site says a session typically takes 30–45 minutes; session count is a main price driver.
Ask each practice what its quote covers and compare like with like.
Is Sofwave or Ultherapy FDA-approved?
Neither — both are FDA-cleared medical devices, not FDA-approved drugs.
Sofwave's latest 510(k) clearance (K250146, 18 Apr 2025) covers facial lines and wrinkles, eyebrow and submental/neck lifting, and short-term cellulite, acne-scar and upper-arm improvement in people 22 and older.
Ultherapy was first authorized through FDA's De Novo pathway in 2009, and its current 510(k) clearance (K260618, 21 May 2026) adds décolleté lines and wrinkles and skin laxity on the abdomen, arms and knees.
Sources
Every number on this page comes from one of these sources and was checked against it.
- accessdata.fda.gov · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Sofwave · sofwave.com
- Patients · sofwave.com
- Safety Information · sofwave.com
- ultherapy.com · ultherapy.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- Ultherapy · ultherapy.com
- FAQs - Ultrasound Treatment, Cost, Side Effects · ultherapy.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- plasticsurgery.org · American Society of Plastic Surgeons
- Thermage · thermage.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Before & After · sofwave.com
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.