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Sofwave: what the FDA has cleared it for and what reviews of ultrasound lifting say

Sofwave uses ultrasound to treat lines, lift the brow and neck, and more. What the FDA's clearances list, from 2021 to 2025, how it differs from Ultherapy in the record, and what to ask.

MedSpaGrades editorial teamUpdated 30 Oct 20263 sources checkedHow we write

At a glance

What it is
Ultrasound treatment
A brand name, made by Sofwave Medical.
FDA-cleared (2021) for
Lines, brow lift, chin and neck lift
Non-invasive, for people aged 22 and older.
FDA status
Cleared, not approved
A clearance is not the same as an approval.
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Sofwave is a brand of ultrasound treatment. The FDA's 2021 clearance of the SofWave System, made by Sofwave Medical, lists it as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax tissue under the chin and in the neck, for people aged 22 and older.1

Here is what the 2021 and 2025 clearances list, what a review says about ultrasound lifting, and what to ask. It gives no settings. Whether to have it is for you and a clinician.

What the FDA record lists

The 2021 clearance covers lines and wrinkles on the face, lifting the eyebrow, and lifting lax tissue under the chin and in the neck, for subjects aged 22 and older.1 The 2025 clearance keeps those uses and adds three: short-term improvement in the appearance of cellulite, the treatment of acne scars, and improving the appearance of skin laxity on the upper arms.1

SofWave uses in the FDA's 2025 record

  • Improve facial lines and wrinkles
  • Lift the eyebrow
  • Lift lax tissue under the chin and in the neck, for people 22 and older
  • Short-term improvement in the appearance of cellulite
  • The treatment of acne scars
  • Improve the appearance of skin laxity on the upper arms

The 2025 summary also covers a separate module, Pure Impact, for improving abdominal tone and strengthening the abdominal muscles, and muscle tone and firmness in the arms, thighs and buttocks.1 Those are muscle uses, not skin uses.

Myth

Sofwave is FDA-approved for the face and the body.

Fact

The FDA cleared the SofWave System in 2021 for the face and neck and extended the clearance in 2025 to cellulite, acne scars and upper-arm skin laxity. A clearance isn't an approval, and the muscle module is a separate part of the system.

FDA 510(k) summaries K211483 and K250146, SofWave System, read 30 Oct 2026

What a review says

A 2023 review describes ultrasound therapy as delivering energy to the dermal and subdermal tissue to induce thermal injury, which leads to collagen remodeling, lifting and tightening. It names Ulthera and Sofwave as the two ultrasound systems with clinically significant results for the eyebrow, under the chin, the neck and fine lines. Its authors stress patient selection and managing expectations.2 The authors call both systems approved. The FDA's letters say cleared. Our Ultherapy page covers the other system.

What med spas name

322 of the 7,475 med spas we list name Sofwave. That doesn't show who runs it or what they treat with it, so ask.3 Which licensed professionals may operate a device depends on your state. See our guide to who may inject.

4%
of the med spas we list name Sofwave322 of 7,475 med spas we list, in 14 states
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Common questions

What is Sofwave cleared for?

The FDA's 2021 clearance lists improving facial lines and wrinkles, lifting the eyebrow, and lifting lax tissue under the chin and in the neck, for people 22 and older. A 2025 clearance adds cellulite, acne scars and upper-arm skin laxity.

Is Sofwave FDA-approved?

It is FDA-cleared, which isn't the same as approved.

What is the difference between Sofwave and Ultherapy?

Both are ultrasound systems the FDA has cleared for the eyebrow and for lax tissue under the chin and in the neck. Their clearance lists differ in other uses. See our Ultherapy page.

Does Sofwave work?

A 2023 review describes clinically significant results for the eyebrow, under the chin, the neck and fine lines, and stresses patient selection. We read its abstract, not the full text.

Sources (3)

  1. FDA 510(k) summaries K211483 (cleared 2021-11-15) and K250146 (cleared 2025-04-18), SofWave System · US Food and Drug Administration, 510(k) database. Both summaries read in full on 30 Oct 2026. The database lists 12 Sofwave Medical entries from 2019 to 2025 (Sofacia, SofWave and Pure Impact); the others were not read. · read 30 Oct 2026
  2. Ultrasound Therapy for the Skin (Facial Plast Surg Clin North Am 2023, PubMed 37806683) · Peer-reviewed review. Abstract read on 30 Oct 2026; full text not read. · read 30 Oct 2026
  3. Clinic websites: what they say on their own pages · Our own read of listed clinics' websites in the 14 states we cover, October 2026. A clinic counts once. · read 30 Oct 2026

Where to go next

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