Aesthetics Biomedical Vivace
RF Microneedling · Robotic 36-gold-needle bipolar RF + LED
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $35k–$55kSource not documented
- Used asking price
- $15k–$28kSource not documented
- 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 ClearedK150409
- 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.
Read FDA-cleared indicationsExact wording from 1 FDA record
K150409 (Sung Hwan E&B Co.,Ltd, 2016)
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
Axis runs $0–$55k. 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 | Aesthetics Biomedical (Cartessa) |
|---|---|
| Company | Not published |
| Parent company | Cartessa Aesthetics |
| Brand owner | Aesthetics Biomedical |
| Built by (OEM) | Aesthetics Biomedical Inc. |
| Category | RF Microneedling |
| Technology | Robotic 36-gold-needle bipolar RF + LED |
| FDA status | FDA Cleared |
| 510(k) citation | K150409 |
| New price range | $35k–$55k |
| Used asking range | $15k–$28k |
| Consumables | Not published |
| Launch year | 2016 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Big med-spa install base; comfort-focused
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K150409 (Sung Hwan E&B Co.,Ltd, 2016)
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — Robotic 36-gold-needle bipolar RF + LED
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
510(k) holder of record
510(k) holder of record: Sung Hwan E&B Co., Ltd — Aesthetics Biomedical (Cartessa) markets, supports and warranties the device in the US.
Parent company: Cartessa Aesthetics
Legal manufacturer: Aesthetics Biomedical Inc. (United States)
Applicant on the FDA record
Sung Hwan E&B Co.,LtdThe 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.
Source notes
Pinova and SO Esthetics tip listings; per-treatment figures derived from pack price and count. 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 Aesthetics Biomedical Vivace 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.
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.
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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, "Aesthetics Biomedical Vivace — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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