Cartessa VirtueRF
RF Microneedling · RF platform with SmartRF and DeepRF bipolar handpieces and an ExactRF monopolar handpiece; configuration determines compatible needle arrays and frequencies.
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- Not published
- FDA status
Record scope: K202415 and K211562 distinguish handpiece/frequency scope. SmartRF at 1 MHz includes percutaneous facial-wrinkle treatment in skin types I–V; the other listed handpiece/frequency configurations do not inherit that wrinkle indication. Overall intended use includes electrocoagulation and hemostasis in dermatologic/general surgery.
- Supplies & recurring costs
- Cartessa references: SmartRF tips $85 each, DeepRF kits $129 each and ExactRF kits $99 each, calculated from different pack prices. These are not a uniform treatment cost.
Sources and 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.
Read FDA-cleared indicationsExact wording from 2 FDA records
K202415 (ShenB Co., Ltd., 2021)
Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2MHz frequency is not intended to treat wrinkles.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K211562 (ShenB Co., Ltd., 2021)
of Virtue RF : The Virtue RF 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: October 7, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | Cartessa (mfg ShenB) |
|---|---|
| Company | Not published |
| Parent company | Not published |
| Brand owner | Cartessa |
| Built by (OEM) | ShenB Co., Ltd. |
| US distributor | Cartessa Aesthetics |
| Category | RF Microneedling |
| Technology | RF platform with SmartRF and DeepRF bipolar handpieces and an ExactRF monopolar handpiece; configuration determines compatible needle arrays and frequencies. |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K202415, K211562 |
| New price range | Not published |
| Used price reference | Not published |
| Consumables | Cartessa references: SmartRF tips $85 each, DeepRF kits $129 each and ExactRF kits $99 each, calculated from different pack prices. These are not a uniform treatment cost. |
| Launch year | 2020 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
VirtueRF is an RF electrosurgical platform manufactured by ShenB and distributed in the United States by Cartessa.
Its configurations include SmartRF and DeepRF bipolar handpieces and a single-needle ExactRF monopolar handpiece; the FDA K211562 summary describes disposable arrays of 36, 12, or 1 needle across the system’s applicators.
The K211562 summary includes a facial-wrinkle indication for SmartRF at 1 MHz in skin types I–V; it does not extend that indication to every handpiece or frequency.
Before purchase, confirm the precise console generation, handpieces, compatible tips, warranty, training, service, and supply terms in a dated written quotation.
How it worksTechnology and manufacturing
How the technology works
Bipolar RF is delivered through 36-needle cartridges with gold-coated insulated needles.
A robotic-precision insertion mechanism motorises needle entry for consistent depth, and the platform splits each RF delivery into sub-pulses, which is what practices most often cite for tolerability under topical anaesthesia alone.
Deep RF targets deeper laxity, Smart RF handles general face and neck passes, and the single-needle Exact RF handpiece enables periorbital and focal work that stamping handpieces cannot match.
Collagen remodelling follows the standard RF-microneedling arc, with visible tightening over weeks and three-session protocols typical.
Patented technology
ShenB's robotic-precision needle-insertion system and the RF sub-pulse energy-fragmentation scheme are the platform's protected differentiators, alongside the insulated gold-coated 36-needle cartridge design.
Origin
Legal manufacturer: ShenB Co., Ltd. (South Korea).
Marketed and serviced in the US by Cartessa Aesthetics.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Oct 6, 2026Record-specific FDA scope reviewed October 6, 2026. K202415 and K211562 distinguish handpiece/frequency scope. SmartRF at 1 MHz includes percutaneous facial-wrinkle treatment in skin types I–V; the other listed handpiece/frequency configurations do not inherit that wrinkle indication. Overall intended use includes electrocoagulation and hemostasis in dermatologic/general surgery. Other records:K202415 and K211562 distinguish handpiece/frequency scope. SmartRF at 1 MHz includes percutaneous facial-wrinkle treatment in skin types I–V; the other listed handpiece/frequency configurations do not inherit that wrinkle indication. Overall intended use includes electrocoagulation and hemostasis in dermatologic/general surgery.
FDA-cleared indications (verbatim)
K202415 (ShenB Co., Ltd., 2021)
Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2MHz frequency is not intended to treat wrinkles.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K211562 (ShenB Co., Ltd., 2021)
of Virtue RF : The Virtue RF 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
RF Microneedling — RF microneedling — 36 gold-coated insulated needles, robotic-precision needle insertion, three handpieces (Smart RF, Deep RF, Exact RF)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Legal manufacturer: ShenB Co., Ltd. (South Korea)
Applicant on the FDA record
ShenB Co., 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.
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
Issued Oct 15, 2025
Scope as FDA lists it
FDA reports serious complications with certain uses of RF microneedling for aesthetic skin procedures, including burns, scarring, fat loss, disfigurement and nerve damage. Some injuries have required surgical repair or other medical treatment.
Reason and action
Discuss potential benefits and risks with a licensed clinician trained in RF microneedling. FDA recommends reporting complications and says these devices should not be used at home.
Read the FDA notice for the devices or procedures covered, reported risks and 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: ShenB Co., 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. Any FDA record cited here must be read for its exact model and scope; it does not automatically cover similar-looking units.
Treatment & running costs
Supplies & recurring costs
Cartessa publicly lists SmartRF tips at $1,700/20 ($85 per tip), DeepRF kits at $1,290/10 ($129 per kit; tip plus lotion), and ExactRF kits at $990/10 ($99 per kit; tip, grounding pad, serum and eye mask). Prices observed October 6, 2026; taxes/shipping not stated.
These are distinct products, not a uniform per-treatment charge.
Source notes
Cartessa publicly lists SmartRF tips at $1,700/20 ($85 per tip), DeepRF kits at $1,290/10 ($129 per kit; tip plus lotion), and ExactRF kits at $990/10 ($99 per kit; tip, grounding pad, serum and eye mask). Prices observed October 6, 2026; taxes/shipping not stated.
These are distinct products, not a uniform per-treatment charge. Product pages: https://www.cartessastore.com/collections/virtuerf/products/virtuerf-deeprf-treatment-kit ; https://www.cartessastore.com/collections/virtuerf/products/virtuerf-exactrf-treatment-kit-pack-of-10
Additional supply notes
Cartessa references: SmartRF tips $85 each, DeepRF kits $129 each and ExactRF kits $99 each, calculated from different pack prices. These are not a uniform treatment cost.
Not yet documented: session schedule, treatment pricing, annual service costs.
Payback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for Cartessa VirtueRF. Published figures appear where available; review them before using the estimate.
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.
New price not published — enter the number on your quote.
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
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Required — include staff time and your own time. Enter 0 only to explicitly exclude labor from this estimate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter purchase price, price you charge per treatment, consumable cost per treatment, labor 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.
Screening considerationsCatalog notes to check against the current instructions for use
Catalog screening notes
Implanted electronic devices such as pacemakers and ICDs, pregnancy, active infection or herpetic outbreak in the treatment field, keloid propensity, recent isotretinoin, and metal implants in the treatment zone.
Insulated needles and conservative settings make the platform workable across Fitzpatrick types, with darker skin types treated conservatively.
These notes are not a complete or verified manufacturer contraindication list. Use the current instructions for the exact device and applicator to determine contraindications, warnings and patient eligibility.
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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RF Microneedling
New-equipment price reference
$35k–$55k
Source not documentedCheck the profile for configuration and price details.
History16 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 7, 2026
Supply compatibility follow-up 2026-10-07
Align summary with existing October 6 source-verified detailed prices. Identify distributor and distinct products instead of a generic OEM per-treatment range; detailed evidence and original verification date retained.
Source: https://www.cartessastore.com/collections/virtuerf
October 6, 2026
FDA indication
Source: Catalog update
October 6, 2026
FDA source URL
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211562.pdf
Source: Catalog update
October 6, 2026
fda status council batch 01 evidence
Claim-specific evidence; not a whole-profile verification.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211562.pdf
October 6, 2026
consumables cost council batch 01 evidence
Claim-specific evidence; not a whole-profile verification.
Source: https://www.cartessastore.com/collections/virtuerf
October 1, 2026
Model and attribution correction
{"parent_company": "Cartessa Aesthetics", "distributor_us": null} → {"parent_company": null, "distributor_us": "Cartessa Aesthetics"}
Cartessa identifies SHENB as the manufacturer. Removed unsupported parent-company attribution while retaining Cartessa brand attribution and recording its distribution role.
Source: https://www.cartessaaesthetics.com/products/virtuerf
September 28, 2026
Safety communication readability
Shortened the October 15, 2025 RF microneedling communication summary after checking the FDA source. Kept all five reported complication types, possible surgical/medical intervention, clinician risk discussion, trained provider and adverse-event reporting guidance. Removed duplicate class-scope text because the public section already labels this as a class communication, not a unit recall. Did not change device associations, action identifiers, dates, status or source. This editorial check does not claim a new complete FDA enforcement sweep.
Source: https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication
September 7, 2026
Cleared indication
decided 01/22/2021 / 11/23/2021 → decided 22 Jan 2021 / 23 Nov 2021
Catalog update — decision dates reformatted to D Mon YYYY (neutral-voice standard, 7 Sep 2026)
Source: Catalog update
September 7, 2026
FDA indication
Source: Catalog record
August 30, 2026
FDA indication
Source: Catalog update
August 30, 2026
New price range
50000-80000 → —
Source: Catalog update
August 30, 2026
Used price range
25000-45000 → —
Source: Catalog update
August 30, 2026
Warranty & service
Source: Catalog update
August 30, 2026
FDA K-numbers
Source: Catalog update
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, "Cartessa VirtueRF — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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