Sofwave Medical Sofwave

HIFU/Ultrasound Lifting · Synchronous Ultrasound Parallel Beam (SUPERB)

CurrentFDA ClearedBe the first to review

What it's actually cleared for: Parallel-beam ultrasound cleared for facial wrinkles, brow lifting, lifting lax submental/neck tissue, cellulite and acne scars

Last verified: August 6, 2026 · How we verify

New: $100k–$150k|Used: $60k–$95kmarket estimate, no email required

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Bottom line

The pragmatic operator's answer to Ultherapy — faster treatments (~30-45 min), less technique-dependence, notably lower discomfort, and near-zero per-treatment consumable cost. Results are real but shallower in mechanism: it's a skin-tightening and fine-lifting device, not a deep SMAS play. Strong pick for a growing medspa that wants premium tightening revenue without Ultherapy's consumable drag. Caveat: patients ask for "Ultherapy" by name; almost nobody walks in asking for Sofwave — you'll do the marketing.

Overview

No-imaging-needed mid-dermis heating; fast sessions

How it works

The science

Synchronous Ultrasound Parallel Beam (SUPERB) — seven parallel non-focused ultrasound beams heat the mid-dermis at a fixed ~1.5mm depth to ~60-70C while integrated cooling protects the epidermis. Targets the dermis rather than the SMAS: collagen/elastin remodeling, tightening, texture, brow and submental lift over 3-6 months. Cleared for facial lines, brow lift, lifting lax submental/neck tissue, short-term cellulite improvement, and acne scars. Fixed depth means less operator skill risk but no deep structural targeting.

Patented tech

SUPERB is the multi-transducer parallel-beam array treating a larger volume per pulse than point-focused HIFU; Sofwave Precise is the integrated contact cooling that keeps treatments tolerable without heavy pain management.

Origin

Israeli company (Yokneam); Israeli-designed and manufactured — verify current production site.

FDA & regulatory status

FDA ClearedCleared via 510(k)

What it's actually cleared for:

Parallel-beam ultrasound cleared for facial wrinkles, brow lifting, lifting lax submental/neck tissue, cellulite and acne scars

510(k) numbers

K211483; K230019; K231537

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

~$2,000-4,500 full face, ~$3,500-6,000 face plus neck, most practices averaging ~$2,500-3,500. One session with optional touch-up at 3-6 months, repeated annually. Body/cellulite areas ~$1,000-2,500.

Consumables & recurring cost

Essentially none — no single-use tips or cards; the applicator has a service life and replacement isn't cheap, and some contracts include utilization terms — read your quote carefully. Near-zero annual consumable budget is the core economic advantage over Ultherapy and Thermage.

Ideal for

Best-fit practice

Injector-led medspas and derm practices wanting a high-margin, delegable tightening add-on — an RN or experienced aesthetician (where state rules allow) can run it after modest training. Sweet spot is 35-60 with mild-to-moderate laxity, including the prejuvenation crowd Ultherapy overshoots.

Compliance

Medical director & delegation

Class II prescription device; most states require medical director oversight and delegation protocols for non-physician operators — verify locally.

Contraindications & screening

Active infection, open lesions or severe acne in the area, implanted electrical devices in the field, pregnancy; screen for recent filler/threads and keloid history.

Ownership

Warranty & service

~1-year warranty typical; extended plans ~$8k-14k/year. Sofwave has pushed subscription/placement acquisition models — sometimes better cash-flow math than purchase.

Resale & used market

Used units (new ~$120k-150k) appearing at ~$60k-90k as the installed base grows; liquidity moderate and improving, prices drifting down as newer applicators ship.