Is Sofwave™ Safe? Side Effects, Skin Types & Who It's For

Sofwave™ is an FDA-cleared, non-invasive ultrasound treatment that does not cut, break, or remove skin. Side effects are uncommon, but if they occur, they are typically mild and short-lived, such as temporary redness, swelling, or tenderness. Sofwave™ is a medical treatment performed only by trained physicians and medical professionals in a clinical setting, who review your medical history to make sure it is right for you. Treatment is not recommended in certain cases, including open wounds or lesions, severe or cystic acne, or electronic implants in the treatment area.

Sofwave™ is FDA-cleared. Under the FDA's 510(k) process, clearance means the device was determined to be substantially equivalent to a legally marketed predicate device. The FDA 510(k) database lists the SofWave System under K250146.

According to the current Sofwave™ Safety Information, the Sofwave™ System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue for subjects aged 22 and older. The Sofwave™ System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars, and is indicated to improve the appearance of skin laxity on the upper arms.

For the full list of indications, contraindications, and precautions, see the official Sofwave™ Safety Information. 

Sofwave™ has a strong safety profile that is built into how the technology works. Its SUPERB™ technology delivers parallel ultrasound beams to an average depth of about 1.5 mm in the mid-dermis, where collagen is produced, without reaching deeper structures such as fat, muscle, or nerves. The proprietary SofCool™ system actively cools the skin's surface throughout treatment, so energy reaches the target layer while the epidermis stays protected.

In the pivotal facial lines and wrinkles study, a prospective multicenter study by Wang and colleagues, co-authored by dermatologists Arielle Kauvar, MD, and Roy Geronemus, MD, and published in Dermatologic Surgery in 2021, 58 participants completed the 12-week follow-up. Fitzpatrick skin types I through VI were represented, and no device-related adverse events were reported.

Other published studies of Sofwave™ reported only temporary effects, such as redness and swelling, that resolved on their own.

Side effects are typically mild and temporary, such as redness, slight swelling, or tenderness, and usually resolve on their own within hours to a few days. For the full list of precautions and potential adverse events, see the official Sofwave™ Safety Information. To learn more, read about whether ultrasound energy is harmful to skin. 

No long-term side effects have been reported in Sofwave™ clinical studies, including a 2024 study by Gold and Biron that followed patients for six months after two treatments. Because Sofwave™ targets the mid-dermis at a controlled depth, it is not designed to affect the fat layer.

A full face and neck Sofwave™ treatment typically takes 30-45 minutes. A topical anesthetic is applied beforehand to keep you comfortable, and most patients return to their daily activities right away. You may notice temporary redness or swelling in the treated area. If anything feels unexpected, your provider is there to help. Unlike a surgical facelift or neck lift, Sofwave™ involves no surgery and no needles; no penetration of the skin is required.

According to the current official safety information, Sofwave™ is contraindicated in certain circumstances.

Sofwave™ should not be used in an area with:

Tell your provider about any implanted medical devices and any active skin condition in or near the proposed treatment area before treatment. The complete current list is available on the official Sofwave™ Safety Information page.

Other medical circumstances may require additional assessment before Sofwave™ treatment.

The official safety information advises additional precaution in situations including:

Sofwave™ treatment is also not recommended directly over an area containing dermal filler, and the system has not been evaluated for use over various implanted materials.

Tell your provider about prescription and non-prescription medications, implants, previous aesthetic procedures, recent skin treatments, and relevant medical conditions. 

You can find a Sofwave™ provider near you to discuss your medical history and suitability for treatment.

Yes. Sofwave™ is safe for all skin types and tones, Fitzpatrick I through VI. Because it uses ultrasound rather than light, it does not target melanin, which is what makes some laser and light treatments riskier for darker skin.

For more on how ultrasound differs from laser and light-based treatments, see common myths about ultrasound facial treatments.

Patients often describe natural-looking results and a comfortable experience with little to no downtime. Hear what two of them had to say. 

In a patient and provider testimonial, Tracy Olson, a medical spa owner and Sofwave™ patient, said, “Absolutely loved the experience.” In a Sofwave™ patient video, another patient said, “I look like myself, just like a better version.”

These testimonials are individual experiences shared by Sofwave™. Individual results may vary.

Consult a qualified provider to determine whether Sofwave™ may be appropriate for you. A provider can review your medical history, medications, implants, previous procedures, treatment area, and individual goals and explain any relevant contraindications or precautions.

Useful questions to ask before treatment include:

For additional guidance, see what to ask your aesthetic doctor before having Sofwave™.

Asking whether a treatment is safe before you book is a smart first step. Sofwave™ is FDA-cleared, requires no needles or surgery, and uses controlled-depth ultrasound with built-in SofCool™ cooling to protect your skin. It is suitable for all skin types, and the side effects reported in clinical studies were mild and temporary. The best next step is a consultation with a Sofwave™ provider, who can confirm it is right for you.

You deserve clear answers before any aesthetic treatment. A qualified Sofwave™ provider can review your medical history, talk through your safety questions, and help you decide whether treatment is a good fit for your goals. Find a Sofwave™ provider near you.