Quick answer
Sofwave is an FDA-cleared ultrasound device that sends parallel beams into the dermis at 1 to 2 mm; Ultherapy focuses ultrasound, with live imaging, at 1.5, 3.0 and 4.5 mm. No head-to-head study was read. The Retreat Clinic offers Ultherapy, not Sofwave.
- Same aim: heat the dermis in small controlled points so that collagen is rebuilt, in people aged 22 and older.
- Different engineering: an array of transducers with active skin cooling for Sofwave; a focused transducer with ultrasound imaging to 8 mm for Ultherapy.
- Evidence: small studies of 42 to 80 people, some linked to the maker; no study compares the two.
- In Malaysia: ask for the model, its Medical Device Authority registration and the name of the person who holds the handpiece.
What is Sofwave?
Sofwave is a non-invasive ultrasound system made by Sofwave Medical of Israel. The US FDA summary describes a console and an applicator: the applicator holds an array of ultrasonic transducers that emit continuous acoustic waves, with an active cooling element on the skin side, and the pulses raise the temperature of the dermis to cause controlled isolated areas of thermal damage. The published papers call this high-intensity, non-focused ultrasound delivered as parallel beams.
The treatment depth in the FDA documents is 1 to 2 mm, with tissue at the heated points at 60 to 70 degrees Celsius. The cooling is there to protect the surface while the dermis is heated.
What is Sofwave cleared for in the United States?
The FDA has cleared it in steps, each time as substantially equivalent to a device already on the market, and the first step named the Ulthera System as its predicate. In September 2019 the Sofacia System was cleared to improve facial lines and wrinkles for people aged 22 and older. In November 2021 the indications grew to include lifting the eyebrow and lifting lax tissue beneath the chin and on the neck.
December 2023 added short-term improvement in the appearance of cellulite, acne scars and upper-arm laxity, and an April 2025 clearance repeats those indications. These are US clearances based on 510(k) summaries. They say what was tested and cleared in the United States, and they are not a statement about Malaysian registration.
How is Sofwave different from Ultherapy?
The table sets out the engineering as the FDA summaries print it. The Ultherapy figures are those of the earlier Ulthera System used as predicate; the newer console is covered in the article on Ultherapy Prime, which found the ultrasound energy identical.
| Feature | Sofwave | Ultherapy |
|---|---|---|
| How the ultrasound is delivered | Array of piezoelectric ceramic plates (parallel beams in the papers) | Focused transducer with a dome-shaped design, moving on a mechanical axis |
| Treatment depth | 1 to 2 mm | 4.5, 3.0 and 1.5 mm |
| Frequency | 10 to 12 MHz | 4 to 10 MHz |
| Tissue temperature at the heated point | 60 to 70 degrees Celsius | 65 degrees Celsius |
| Ultrasound imaging while treating | Not listed in the summaries | Visualisation to 8 mm with the DeepSEE transducer |
| Active skin cooling | Required | Not required |
| Treatment area width | 35 mm (2021 summary) | 25 mm |
What follows from the table is a difference in design, not a verdict. A shallower depth reaches the dermis only; a choice of depths with imaging lets the operator confirm skin contact and avoid bone, as the Ultherapy summary describes. Which suits a given face depends on the skin, the area and the sagging, which an assessment decides.
What do the published studies on Sofwave show?
The FDA study behind the 2021 clearance treated 80 people at five US sites. At three months the treating doctors judged 80 per cent (51 of 64) improved at the brow and 85 per cent (61 of 72) improved beneath the chin and on the neck, and measured an average lift of 0.78 mm in maximal eyebrow height and 38 mm2 in submental and neck tissue.
A 2026 Hong Kong study of 42 Asian adults, after a single treatment, found 83.3 per cent better submental and neck laxity at three months, 28.6 per cent better eyebrow elevation and 38.1 per cent fewer wrinkles, with the volume change in the jawline not reaching significance (1.04 ml, p = 0.06). Biopsies in a 2025 paper showed collagen, elastin and glycosaminoglycans still rising ten months after treatment. Two authors of that paper work for the maker, and none of these studies has a randomised comparison group.
Does Sofwave hurt, and what are the side effects?
The studies report moderate discomfort. Mean pain was 7.49 out of 10 in the first FDA study, called moderate by its summary, while the arm study reported mostly none to mild pain and the Hong Kong study described the treatment as well tolerated. Scales, settings and numbing differ between studies, so these figures cannot be set against those in the Ultherapy comfort article.
The reported effects are temporary redness and swelling: in Hong Kong, 50 per cent and 7.2 per cent, with no other adverse event, and no device-related adverse events in the FDA studies. Rare effects are less likely to appear in groups of 15 to 80 people, which is a reason to read small studies with care.
Is Sofwave the same as HIFU?
The FDA documents list the energy type as high-intensity ultrasound, and the papers call it non-focused. In the words of Dr Ong, HIFU is a copy of Ultherapy. The checkable record is this: the FDA summary K134032 records Ulthera's De Novo submission and its 510(k) clearance of 11 September 2009 as a new type of device, and the first Sofwave clearance lists the Ulthera System as its predicate. The guide to Ulthera, Ultherapy and HIFU sets out the names.
What are the Malaysian rules for a device like Sofwave?
Two things apply, and neither is settled by a brand name. A medical device must be registered with the Medical Device Authority, and since 1 June 2026 a person operating a designated device needs a designated medical device permit; the article on the 2026 Order explains it. The Order names focused ultrasound for tightening or fat reduction, and whether a particular device sits inside that description is decided by the Order and the Authority.
This article did not search the register for Sofwave. The practical checks are the same as for any device: ask for the model and its registration number, search it at mdar.mda.gov.my, ask where the device was bought, and ask who holds the handpiece. Before you book a low-priced HIFU lists the questions.
Does The Retreat Clinic in Setia Alam offer Sofwave?
No. Dr Ong performs Ultherapy at the clinic, after an assessment of whether it suits the face and the sagging. The Ultherapy page sets out the treatment. Sofwave is described here as education, so that a reader who meets the name elsewhere knows what the documents say.
