What Is Sofwave?

FDA's 510(k) summaries describe a system that "generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage." The handpiece contains an array of ultrasonic transducers and an active cooling element that cools the skin surface during treatment.

In the comparison table filed for its 2022 clearance, 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) technology with integrated "Sofcool" cooling and says the energy is centered in the mid-dermis at 1.5 mm.

FDA "clearance" means a 510(k) found the device substantially equivalent to a legally marketed device for the listed uses. It isn't the same as FDA approval of a drug.

Each clearance was supported by a company study summarized by FDA. In most, blinded reviewers were shown before and after photos and asked to pick which was which. The results:

• Facial lines and wrinkles (2019):
  • 59 people were treated;
  • reviewers correctly identified the before and after photos for 78% at 12 weeks;
  • 72% of subjects said their wrinkles looked better, and 59% were satisfied.
• Brow, under-chin and neck (2021):
  • 80 people were treated at five U.S. sites;
  • reviewers correctly identified photos for 79% for the brow and 80% for the submental and neck area;
  • the measured average brow lift was under 1 mm (0.78 mm at maximal eyebrow height).
• Cellulite (2022): 68 people had two treatments 2–4 weeks apart. Reviewers correctly identified post-treatment photos for 89% at three months.
• Upper arms (2023): 46 people had two sessions 1–3 weeks apart. Blinded reviewers judged 93% of treated arms improved at three months.

These were small studies run by the manufacturer, with follow-up of about three months. They show measurable but modest changes and don't show how long results last.

• Pain: in the 2019 facial study the mean pain score was 7.49, which FDA's summary calls "moderate pain"; no one withdrew because of pain. In the 2023 upper-arm study, most subjects reported no or mild pain. Some practices use a topical anesthetic.
• Reactions: FDA's summaries report no device-related adverse events in the 2019 and 2023 studies. Expected tissue responses in the arm study were redness and swelling that went away on their own.
• Labeled adverse events: the company's safety information lists possible "significant pain, tenderness, changes in skin pigmentation, persistent erythema and edema, ulceration/erosion and/or bruising."
• Downtime: the company says patients can resume daily activities right after treatment. Ask your clinician what to expect for your area and settings.

The manufacturer's labeling lists these contraindications in the treatment area:

• open wounds or lesions;
• severe or cystic acne;
• pacemakers or electronic device implants.

It lists precautions including:

• pregnancy, giving birth within three months, or breastfeeding;
• active infection or skin disease;
• significant scarring;
• metal stents or implants in the face;
• treating directly over dermal filler;
• isotretinoin or another retinoid in the past 6 months;
• psychiatric drugs, anti-platelet or anti-coagulant drugs in the past 2 weeks.

Skin types: the company says Sofwave is safe for all skin types. FDA's cleared indications don't address skin type, so ask your dermatologist about your skin and any pigmentation history.

• Ultherapy is also ultrasound under the same FDA regulation, but it uses a focused transducer with ultrasound imaging. In the FDA comparison table for Sofwave's first clearance, Ultherapy's treatment depths were 4.5 mm and 3 mm, compared with 1–2 mm for Sofwave. See What Is Ultherapy?
• RF microneedling (for example, Morpheus8) uses radiofrequency energy delivered through pins that enter the skin, so it isn't non-invasive and has some recovery. See What Is RF Microneedling? and Morpheus8 vs. Ultherapy.
• None of these replaces a facelift or neck lift. For an overview of every option, see What Is Skin Tightening?

• Which FDA-cleared indication fits my concern, and is my area one of them?
• What results have you seen for someone with my skin type and degree of laxity?
• How many sessions do you plan, and why?
• What will I feel, and what numbing do you use?
• Do I have anything on the contraindication or precaution list, such as fillers or implants in the area, a recent retinoid, or blood thinners?
• 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. Anna Chacon, a board-certified dermatologist and Diplomate of the American Board of Dermatology who founded Miami Derm, a medical, surgical and cosmetic dermatology practice in Miami. Browse Dermatology in Find a Doctor. Listed doctors are paid members of the Haute MD Network. Editorial selection, not a ranking.

Related

• What Is Skin Tightening?
• What Is Ultherapy?
• What Is RF Microneedling?
• How Are Acne Scars Treated?
• What Is Neck Lift Surgery?

• FDA 510(k) summaries, Sofwave Medical Ltd.: K191421, K211483, K223237, K233104, K232455, K250146 (fetched Nov. 4, 2026)
• openFDA, Device 510(k) API, product code OHV (data updated Oct. 26, 2026; fetched Nov. 4, 2026)
• 21 CFR §878.4590, focused ultrasound stimulator system for aesthetic use (eCFR; fetched Nov. 4, 2026)
• Sofwave Medical, Safety Information, Providers FAQ and homepage (manufacturer; fetched Nov. 4, 2026)
• American Academy of Dermatology, Many ways to firm sagging skin (fetched Nov. 2, 2026)

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.