Aesthetics Biomedical Vivace Ultra
RF Microneedling · RF microneedling + ultrasound skin visualization
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $60k–$90kReported source: Dealer quote · Aug 12, 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
- FDA ClearedK221574
- 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.
Latest price source dated: Aug 12, 2026
·FDA database · Updated Aug 12, 2026Read FDA-cleared indicationsExact wording from 1 FDA record
K221574 (Aesthetics Biomedical, 2022)
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 22, 2026 · How we verify
Axis runs $0–$90k. Reference figures, not current offers.
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 | Aesthetics Biomedical (Cartessa) |
|---|---|
| Company | Not published |
| Parent company | Cartessa Aesthetics |
| Brand owner | Aesthetics Biomedical |
| Built by (OEM) | Aesthetics Biomedical Inc. |
| Category | RF Microneedling |
| Technology | RF microneedling + ultrasound skin visualization |
| FDA status | FDA Cleared |
| 510(k) citation | K221574 |
| New price range | $60k–$90k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2023 |
| Latest price source dated | Aug 12, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
First RF-MN with built-in ultrasound imaging
How it worksTechnology and manufacturing
How the technology works
Insulated microneedles fire RF into the dermis to heat tissue, contract collagen, and trigger remodeling for wrinkles, laxity, scars, texture.
The Ultra's headline: a linear-array ultrasound in the workflow images skin before treatment so depth settings match actual tissue thickness by area — meaningful on thin-skinned zones like periorbital and neck where fixed-depth protocols over- or under-treat.
Retains the Vivace formula: 36-needle gold-tipped array with precision robotic insertion (the comfort reputation), depths to ~3.5mm, red/blue LED modes, and the branded Vivace Experience serum + cooling peptide mask protocol.
Patented technology
The ultrasound visualization system is the genuinely novel piece — imaging-guided depth selection no other US RF-MN platform ships (FDA-cleared via the ASCA pathway). The gold-plated robotic insertion tip is refinement, and the reason for the comfort claims.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Aug 12, 2026Clearance K221574Clearance 2022 · Launch 2023 · K221574
FDA-cleared indications (verbatim)
K221574 (Aesthetics Biomedical, 2022)
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — RF microneedling + ultrasound skin visualization
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: Cartessa Aesthetics
Legal manufacturer: Aesthetics Biomedical Inc. (United States)
Applicant on the FDA record
Aesthetics BiomedicalThe 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.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- FDA safety communicationFDA safety communication, issued 15 October 2025Open
Initiated Oct 15, 2025
Scope as FDA lists it
Applies to RF microneedling devices used for dermatologic or aesthetic procedures intended to improve the appearance of the skin. FDA is aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, and of injuries needing surgical repair.
FDA advises providers to discuss these risks with patients and to report complications.
Reason and action
FDA advises providers to discuss these risks with patients before treatment, to use devices only as cleared, and to report complications to MedWatch. FDA did not name individual brands; the communication covers 510(k)-cleared RF microneedling devices as a class.
This communication applies to a class of devices, not to a specific unit or recall.
This is an FDA communication about a device class, not a recall of specific units; read the FDA notice for the reported risks and FDA's recommendations.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Look-alike devices
Comparing an unbranded RF microneedling unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Aesthetics Biomedical 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.
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 Aesthetics Biomedical Vivace Ultra 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
Pacemakers/ICDs and implanted electronics, pregnancy, active infection or inflammatory skin disease, recent isotretinoin, keloid history, metal implants near the zone. Gold-needle allergy is rare but belongs on the intake form.
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
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History7 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 22, 2026
Manufacturing origin evidence
Withdrew speculative manufacturing-origin wording without documented manufacturer-attribution evidence. Country of manufacture is not established by a brand headquarters, another model, or an assumed OEM relationship. Original text retained; no replacement origin asserted.
Source: Catalog update
September 22, 2026
technology subcategory
HIFU / Ultrasound → RF Microneedling
Corrected technology grouping from HIFU / Ultrasound to RF Microneedling. Manufacturer describes ultrasound imaging guidance alongside RF microneedling. Original classification preserved; no model, availability, clinical, pricing or review changes.
Source: https://aestheticsbiomedical.com/awards-press/
September 4, 2026
FDA indication
Source: Catalog update
August 5, 2026
FDA indication
Source: Catalog update
August 5, 2026
FDA indication
Source: Catalog update
August 5, 2026
FDA K-numbers
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, "Aesthetics Biomedical Vivace Ultra — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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