Cartessa VirtueRF
RF Microneedling · RF microneedling — 36 gold-coated insulated needles, robotic-precision needle insertion, three handpieces (Smart RF, Deep RF, Exact RF)
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
Technology: RF Microneedling
Work at Cartessa (mfg ShenB)? Claim your company's profiles free — one claim covers all 3 of your devices.
Decision card
- New price band
- Quote only — not published
- Used asking band
- No verified used range yet
- FDA status
- Consumables / lock-in
- A per-treatment consumable is required
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
A per-treatment figure may appear in the Economics discussion below without qualifying for this panel — the panel publishes only a typed value with a date and a source; where a recurring consumable is documented but unpriced, the calculator asks you for a per-treatment figure before it computes anything, and where no recurring consumable is documented it uses zero and says so.
Researched US market figures, not manufacturer quotes. Sources are listed on this page where a primary source exists; unsourced values are labeled. All Cartessa (mfg ShenB) devices
Cartessa VirtueRF pricing is not published by the manufacturer, and we have not yet verified a US market range. Cartessa VirtueRF holds FDA 510(k) clearance for its marketed indication.
What it's actually cleared for: “Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2MHz frequency is not intended to treat wrinkles.” K202415
Page updated: September 7, 2026 · How we verify
New purchase price: quote only. This manufacturer does not publish list pricing. We publish verified figures only — no estimates.
Price sourcing detailWhere each band comes from and what configuration it covers
Key factsFull record: company, category, clearance, prices, verification dates
| Manufacturer | Cartessa (mfg ShenB) |
|---|---|
| Company | Not published |
| Parent company | Cartessa Aesthetics |
| Brand owner | Cartessa |
| Built by (OEM) | ShenB Co., Ltd. |
| Category | RF Microneedling |
| Technology | RF microneedling — 36 gold-coated insulated needles, robotic-precision needle insertion, three handpieces (Smart RF, Deep RF, Exact RF) |
| FDA status | FDA Cleared |
| 510(k) citation | K202415, K211562 |
| New price range | Not published |
| Used asking range | Not published |
| Consumables | Sterile single-use tip every treatment — OEM list $85–$129 per tip/kit. |
| Launch year | Not published |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Owner experience: Owner and operator reviews (Attested or Verified) appear here as they are published. Write a review.
Overview
Three interchangeable handpieces (Smart RF, Deep RF, Exact RF) on one platform. Alternatives buyers shortlist alongside it: Morpheus8, Secret RF, Potenza, Vivace Ultra, Genius.
How it worksScience, patented technology and origin
The science
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 tech
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
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.
Parent company: Cartessa Aesthetics
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 is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.
FDA safety actions
Recalls, warning letters and safety communications recorded in FDA's public databases for this record, transcribed as FDA lists them. Terminated actions are shown as history, not as an open issue. Every manufacturer is documented the same way — what we publish about legal and safety matters.
Checked 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 /claim.
FDA record
Look-alike devices
The cleared device in this class on this page is made by ShenB Co., Ltd.. Unbranded RF microneedling units are sold online at a fraction of this platform’s price, often using the same marketing images and treatment claims. We have not located a US 510(k) naming these units (checked 7 September 2026). For unbranded units we have not verified warranty terms, training, consumables supply, service coverage or financing availability — ask the seller for written terms and confirm the model, applicant and 510(k)/De Novo number on the FDA database before buying. The Aesthetic Index does not profile these devices.
Treatment economics
Typical protocol
Not published — owners are asked in every review, and this section fills in from their answers.
Verified session pricing not on file yet — any ranges in the narrative above are unverified estimates.
Consumables & recurring cost
Every VirtueRF treatment uses a sterile single-use tip matched to the handpiece. Cartessa's own store lists SmartRF tips at $1,700 / 20 ($85 each), ExactRF kits $990 / 10 ($99 each) and DeepRF kits $1,290 / 10 ($129 each). Secondary-market singles are cheaper ($70–$139) but are aftermarket, not OEM. Use OEM pricing for budgeting.
Consumables (summary)
Sterile single-use tip every treatment — OEM list $85–$129 per tip/kit.
Consumable-free
No — a per-treatment consumable is required
Annual service & support
Not documented yet.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
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.
Warranty & serviceWhat to confirm in writing before you buy
Confirm current warranty, training and service terms in writing before purchase, new or used.
Chains using this device
No confirmed chain deployments recorded yet.
Owner & operator reviews
Write a reviewDevice user rating publishes at 3 reviews. Methodology.
No owner or operator reviews yet. Be the first →
Alternatives
InMode Morpheus8
RF Microneedling · $40k–$120k depending on configuration (standalone Morpheus8 console $40k–$60k; InMode multi-handpiece platform bundle $80k–$120k)
Head-to-head comparisons buyers ask for
History9 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
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
Warranty & service
Source: Catalog update
August 30, 2026
FDA K-numbers
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 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 September 13, 2026).
Get the full State of Aesthetic Devices 2026 report
A catalog of 479 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. Prices are researched estimates, not quotes. Not medical, legal or regulatory advice.