Classys Ultraformer III
HIFU/Ultrasound Lifting · 7-cartridge HIFU face/body
Technology: HIFU & Ultrasound
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- Not published
- Used asking price
- $20,700–$47,900Reported source: Used listing · Aug 30, 2026
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- No US 510(k) located — checked 4 Sep 2026
- 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.
Latest price source dated: Aug 30, 2026
Page updated: September 7, 2026 · How we verify
No new-equipment price range is published for this model. Ask the seller for a dated, itemized quote covering configuration, training and service.
Axis runs $0–$47,900. 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 | Classys |
|---|---|
| Company | Owner: Bain Capital (majority, being reduced) plus the founder Jung Sung-jae family (minority) (private equity owned, since 2022) · Distribution: hybrid (direct + distributor) — Cartessa Aesthetics (Volnewmer RF, US-branded Everesse, in North America) |
| Parent company | Bain Capital |
| Brand owner | Classys |
| Built by (OEM) | Classys Inc. |
| Category | HIFU/Ultrasound Lifting |
| Technology | 7-cartridge HIFU face/body |
| FDA status | No US 510(k) located |
| New price range | Not published |
| Used asking range | $20,700–$47,900 |
| Consumables | Not published |
| Launch year | 2016 |
| Latest price source dated | Aug 30, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
Dominant HIFU brand outside US
How it worksTechnology and manufacturing
How the technology works
Delivers micro- and macro-focused ultrasound (Classys's MMFU) to precise depths — 1.5, 2.0, 3.0, and 4.5mm cartridges for face plus 6, 9, and 13mm for body — creating discrete thermal coagulation points at 65-75C without disturbing the surface.
The 4.5mm depth targets the SMAS layer, the same plane a surgical facelift tightens. Contraction is immediate with collagen remodeling over 2-3 months, backed by international literature and a large Asian clinical consensus base.
Shoots faster than Ultherapy and, per most operators, with less pain — though it lacks Ultherapy's ultrasound visualization.
Patented technology
Classys's MMFU cartridge system and high-speed shot delivery, with one of the widest cartridge depth ranges in HIFU.
Origin
Seoul, South Korea (Classys Inc.).
FDA & regulatory detailClearance timeline, authorization route and citation notes
No US 510(k) was located for this model (checked 4 Sep 2026). Lenders and insurers may ask for regulatory documentation before financing or covering a device without US clearance.
FDA-cleared indications (verbatim)
Not published — no US clearance located for this model.
Marketed for
HIFU / Ultrasound — 7-cartridge HIFU face/body
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Bain Capital
Legal manufacturer: Classys Inc. (South Korea)
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: Classys Inc.
- 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
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
Source notes
BioSkin EU cartridge and gel listings. Currencies as published, not converted.
30 Aug 2026 research pass.
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 Classys Ultraformer III 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 used asking 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
Pregnancy, severe active acne or open lesions, metal implants or fillers directly in the treatment plane, anticoagulant concerns, careful energy selection over the thyroid and major nerve territories. Operator training matters more than usual — there's no US manufacturer clinical support to lean on.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
No confirmed chain deployments recorded yet.
Owner & operator reviews
Write a reviewNo owner or operator reviews yet. Be the first →
Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 7, 2026
parent company
Classys → Bain Capital
Ultimate owner updated against a dated primary source (8 Sep 2026); controlling stake dates to 2022, not 2024.
Source: https://pulse.mk.co.kr/news/english/10281340
September 4, 2026
FDA indication
Source: Catalog update
August 30, 2026
Used price range
10000-25000 → 20700-47900
Source: Catalog update
August 5, 2026
Editorial profile
Full profile published including US regulatory status — August 2026.
Source: Editorial (admin)
August 5, 2026
Warranty & service
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Classys Ultraformer III — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
Get the full State of Aesthetic Devices 2026 report
A catalog of US-marketed aesthetic and wellness devices — preview it free.
Device and company names are trademarks of their respective owners. The Aesthetic Index is not affiliated with or endorsed by any manufacturer, distributor or lender named here, except as disclosed. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.