Sofwave
HIFU/Ultrasound Lifting · Synchronous Ultrasound Parallel Beam (SUPERB)
Technology: HIFU & Ultrasound
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $100k–$150kSource not documented
- Used asking price
- $60k–$95kSource not documented
- FDA status
- Supplies & recurring costs
- Treatment capacity is bought as a pulse-purchase licence (Sofwave provider FAQ and terms). US per-pulse price not publicly disclosed.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Manufacturer-source documents checked: August 31, 2026
Read FDA-cleared indicationsExact wording from 2 FDA records
K211483 (Sofwave Medical, Ltd., 2021)
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; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K230019 (Sofwave Medical, Ltd., 2023)
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; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 31, 2026 · How we verify
Axis runs $0–$150k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Sofwave Medical |
|---|---|
| Company | Owner: Publicly traded (Tel Aviv Stock Exchange: SOFW) (public company, since 2021) · Distribution: direct |
| Parent company | Sofwave Medical |
| Brand owner | Sofwave Medical |
| Built by (OEM) | Sofwave Medical Ltd. |
| Category | HIFU/Ultrasound Lifting |
| Technology | Synchronous Ultrasound Parallel Beam (SUPERB) |
| FDA status | FDA Cleared |
| 510(k) citation | K211483, K230019, K231537 |
| New price range | $100k–$150k |
| Used asking range | $60k–$95k |
| Consumables | Treatment capacity is bought as a pulse-purchase licence (Sofwave provider FAQ and terms). US per-pulse price not publicly disclosed. |
| Launch year | 2021 |
| Pricing | Not published |
| Manufacturer-source documents checked | August 31, 2026 |
Overview
No-imaging-needed mid-dermis heating; fast sessions
How it worksTechnology and manufacturing
How the technology works
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 technology
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 detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K211483 (Sofwave Medical, Ltd., 2021)
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; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K230019 (Sofwave Medical, Ltd., 2023)
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; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — Synchronous Ultrasound Parallel Beam (SUPERB)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Sofwave Medical
Legal manufacturer: Sofwave Medical Ltd. (Israel)
Applicant on the FDA record
Sofwave Medical, Ltd.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Look-alike devices
Comparing an unbranded HIFU (focused ultrasound) unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Sofwave Medical Ltd.
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
We do not profile these unbranded units or verify their support and financing terms. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Treatment capacity is licensed, not free: Sofwave sells pulses under a pulse-purchase license per its own provider FAQ and terms, and used units require Sofwave inspection to restore e-store access. The US per-pulse price is not publicly disclosed — get it in writing before modeling per-session margin.
- Vendor restrictions: card-metered — license cards or dongles gate treatments
Source notes
Sofwave provider FAQ and terms: pulse-purchase licence; inspection required to restore e-store access on used units. US per-pulse price not publicly disclosed.
Additional supply notes
Treatment capacity is bought as a pulse-purchase licence (Sofwave provider FAQ and terms). US per-pulse price not publicly disclosed.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Sofwave data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the midpoint of the published new-price range
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
ComplianceScreening and contraindications on the manufacturer's record
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.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
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Current alternatives
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Research comparisons
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History1 tracked change
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Sofwave — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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