
FDA-Cleared Ultrasound · SofWave
Sofwave
Sofwave (SUPERB ultrasound) in Seoul — FDA-cleared mid-dermis lifting for facial lines, eyebrow, neck, and skin laxity. Single session, minimal downtime.

Lifting Comparison
Sofwave vs Ultherapy — two FDA-cleared ultrasound lifting options compared by depth, evidence, downtime and session, with where Korean HIFU (Shurink) and Thermage fit.
In This Guide
Sofwave vs Ultherapy — two FDA-cleared ultrasound lifting options compared by depth, evidence, downtime and session, with where Korean HIFU (Shurink) and Thermage fit.

Section 1 / 6
Sofwave and Ultherapy are both FDA-cleared ultrasound lifting devices — but they work at different depths. Sofwave delivers Synchronous Ultrasound Parallel Beam (SUPERB) energy to the mid-dermis (about 1.5 mm), while Ultherapy (microfocused ultrasound, MFU-V) reaches deeper to the SMAS layer (up to 4.5 mm). In practice, Sofwave suits skin quality, fine lines and early laxity in a single short session; Ultherapy suits deeper, structural lifting of the jowls and jawline. Both are offered at Delight Dermatology and selected by examination, not by marketing.
Korean HIFU devices such as Ultraformer MPT (branded Shurink) work at similar SMAS depths to Ultherapy but hold MFDS and CE clearance rather than FDA clearance. Thermage is a different category — radiofrequency, not ultrasound.
Section 2 / 6
| Feature | Sofwave | Ultherapy | Korean HIFU (Ultraformer / Shurink) | Thermage |
|---|---|---|---|---|
| Energy | SUPERB parallel ultrasound | Microfocused ultrasound (MFU-V) | Micropulsed HIFU | Monopolar radiofrequency |
| Main depth | Mid-dermis (~1.5 mm) | SMAS (up to 4.5 mm) | SMAS (1.5–4.5 mm) | Dermis (bulk heating) |
| Regulatory | FDA-cleared · CE · MFDS | FDA-cleared · MFDS | MFDS · CE (not FDA) | FDA-cleared · MFDS |
| Sessions | Single session | Single session | Course (e.g. 3–5) | Single session |
| Best suited to | Fine lines, skin quality, early laxity, neck | Deeper structural lift, jowls, jawline | SMAS lift at lower cost | Crepey skin, dermal tightening |
| Downtime | Minimal | Minimal | Minimal | Minimal |
Both Sofwave and Ultherapy are individualised by the dermatologist; the table is a general guide, not a substitute for examination.
Section 3 / 6
The most useful way to understand these devices is by depth. Sofwave concentrates energy in the mid-dermis at about 1.5 mm, preserving the epidermis with integrated cooling, to stimulate new collagen and elastin where fine lines and surface laxity live (Carruthers et al., 2025, PMID 41405933). Ultherapy and Korean HIFU reach the deeper SMAS — the connective-tissue layer a surgeon mobilises during a facelift — for structural lifting of the jowls and jawline.
Neither is universally better. A patient with good skin who wants refinement in a single short session is often a Sofwave candidate; a patient with heavier jowl descent who wants a deeper lift is often an Ultherapy candidate. Most patients fit one clearly after examination.
Section 4 / 6
For ultrasound lifting, regulatory status is a genuine point of difference. Sofwave holds FDA 510(k) clearance K211483 for improving facial lines and wrinkles, lifting the eyebrow, and lifting lax submental (under-chin) and neck tissue. Ultherapy is FDA-cleared for brow lift (2009), submental and lateral neck laxity (2012), and décolletage lines (2014). Thermage is FDA-cleared as a monopolar radiofrequency device.
Korean HIFU devices (Ultraformer MPT / Shurink) hold MFDS and CE records; no FDA record was identified for them. This is a difference in which records exist, and nothing more. It does not establish whether a manufacturer ever applied, and a 510(k) clearance is a finding of substantial equivalence to a legally marketed device — not a grade of clinical evidence, and not a determination of safety or efficacy.
Section 5 / 6
Sofwave: a single-treatment study of 42 Asian patients reported improvement in submental and neck laxity in 83.3% of patients at three months, with eyebrow elevation improved in 28.6% and facial wrinkles in 38.1% of patients at the same point; wrinkle and elastosis improvement persisted to nine months in 12.8% (Chung et al., 2026, PMID 42226470). Histology shows long-term dermal collagen and elastin remodelling after SUPERB ultrasound, in a study co-authored by the manufacturer (Carruthers et al., 2025, PMID 41405933).
Ultherapy, Korean HIFU and Thermage are covered in depth in our HIFU vs Ultherapy evidence guide, Korean HIFU devices guide, and Thermage vs Ultherapy guide.
Section 6 / 6
At consultation, the dermatologist examines skin quality, laxity grade and the layers involved, then matches the device to the anatomy — not the other way around. Sofwave and Ultherapy can also be sequenced or combined with other modalities in a planned course. Pricing and the exact plan are confirmed at consultation.
See the procedure pages for details: Sofwave, Ultherapy, and Thermage.
FAQ
HIFU is a category of focused-ultrasound treatment rather than one device, and in Seoul it usually means a Korean platform such as Ultraformer MPT (Shurink) reaching the SMAS at up to about 4.5 mm. Sofwave is a different design: Synchronous Ultrasound Parallel Beam energy delivered to the mid-dermis at about 1.5 mm with integrated surface cooling. Depth is the practical difference — mid-dermis work suits fine lines, skin quality and early laxity, while SMAS-depth work suits structural lifting. Sofwave holds FDA 510(k) clearance K211483; Ultraformer MPT holds MFDS and CE records but no FDA record.
They treat different layers. Ultraformer MPT, sold in Korea as Shurink, delivers micropulsed HIFU to the SMAS at up to about 4.5 mm. Sofwave delivers parallel-beam ultrasound to the mid-dermis at about 1.5 mm in a single session. Ultraformer MPT holds MFDS and CE records; Sofwave holds FDA 510(k) clearance K211483. Neither replaces the other — the choice follows skin thickness and where the laxity actually sits, which is assessed at consultation.
Neither is universally better — they work at different depths. Sofwave targets the mid-dermis (about 1.5 mm) and suits fine lines, skin quality and early laxity in a single short session; Ultherapy reaches the deeper SMAS (up to 4.5 mm) and suits structural lifting of the jowls and jawline. Both are FDA-cleared, and the right choice is decided by examination.
Both Sofwave and Ultherapy are FDA-cleared. Sofwave is cleared for facial lines and wrinkles, eyebrow lift, and lifting of submental and neck tissue; Ultherapy is cleared for brow, submental and lateral neck, and décolletage. Korean HIFU devices such as Ultraformer MPT (Shurink) hold MFDS and CE marking but not FDA clearance.
No. Sofwave uses Synchronous Ultrasound Parallel Beam (SUPERB) energy at the mid-dermis and is FDA-cleared, while Korean HIFU devices such as Ultraformer MPT (Shurink) deliver micropulsed HIFU to the deeper SMAS and hold MFDS and CE clearance rather than FDA clearance.
Results build gradually as new collagen forms over roughly two to three months. For Sofwave, improvement has been reported sustained up to about nine months in clinical study, with re-treatment generally considered every 6–12 months; Ultherapy results typically last around 12–18 months. Individual results vary with skin and lifestyle.
Both are generally well tolerated with topical comfort measures. Sofwave uses integrated cooling and a parallel-beam design to keep discomfort low; Ultherapy can feel more intense at the deeper 4.5 mm setting over bone. Comfort options are discussed at consultation.
Related Procedures
If you need more detail about treatment approach, recovery, or suitability, continue into these procedure pages.

FDA-Cleared Ultrasound · SofWave
Sofwave (SUPERB ultrasound) in Seoul — FDA-cleared mid-dermis lifting for facial lines, eyebrow, neck, and skin laxity. Single session, minimal downtime.

Non-surgical Lifting
Ultherapy is a brand-name microfocused-ultrasound platform with imaging. Published studies report variable change in selected patients; candidate selection, anatomy, area, transducer, settings, risks, recovery, and expectations require individual assessment. It does not guarantee lifting or replace surgery.

Solta Medical · AccuREP Technology
Thermage FLX is a monopolar radiofrequency platform. Published studies report variable and generally modest tightening in selected patients; tip, area, settings, risks, recovery, and expectations require individual assessment. It does not guarantee jawline change or replace surgery or volume treatment.