ilooda Fraxis Duo
CO2 Fractional/Ablative · Fractional CO2 + RF microneedling
Technology: RF Microneedling
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- $60k–$90kSource 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 ClearedK160312
- 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.
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Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 1 FDA record
K160312 (Ilooda Co., Ltd., 2016)
CO2 Laser part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. HF electrosurgical part: The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 7, 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 | ilooda (Cutera dist.) |
|---|---|
| Company | Owner: Bain Capital, via Classys Inc. (absorbed 2025) (subsidiary, since 2023) · Distribution: hybrid (direct + distributor) |
| Parent company | Cutera |
| Brand owner | ilooda |
| Built by (OEM) | Ilooda Co., Ltd. |
| Category | CO2 Fractional/Ablative |
| Technology | Fractional CO2 + RF microneedling |
| FDA status | FDA Cleared |
| 510(k) citation | K160312 |
| New price range | $60k–$90k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2017 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Korean CO2/RF combo platform
How it worksTechnology and manufacturing
How the technology works
The CO2 side is a conventional 10,600nm fractional ablative laser (fractional, pulsed, and surgical modes) that vaporizes microcolumns of tissue for wrinkles, scars, and lesion work — the gold-standard resurfacing physics.
The RF side is ilooda's Secret technology: motorized microneedle cartridges (25- and 64-pin, semi-insulated or non-insulated, adjustable to ~3.5mm) delivering bipolar RF at depth for dermal remodeling without surface injury.
Stacked in one session, the CO2 addresses epidermal texture and pigment while the RF needles remodel the deeper dermis — the combination underlies the "Secret Pro"-style protocols now backed by multi-center data on scars and photoaging. Two mechanisms, one numbing session, compounding results.
Patented technology
ilooda's Secret motorized needle-insertion mechanism with semi-insulated needle design is the signature IP — semi-insulation delivers energy along the distal needle segment for a larger coagulation zone than fully insulated designs. The platform integrates both modalities in a single system.
Origin
South Korea (ilooda Co., Ltd., Suwon); the same factory lineage supplying Cutera's US-branded Secret devices.
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K160312 (Ilooda Co., Ltd., 2016)
CO2 Laser part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. HF electrosurgical part: The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — Fractional CO2 + RF microneedling
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: Cutera
Legal manufacturer: Ilooda Co., Ltd. (South Korea)
Applicant on the FDA record
Ilooda 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
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: Ilooda 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. 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 ilooda Fraxis Duo 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.
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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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Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
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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
For CO2: darker Fitzpatrick types (relative), active infection, isotretinoin history, keloids, pregnancy, and mandatory HSV prophylaxis perioral.
For RF-MN: implanted electronic devices and field metal; the combo session concentrates both risk profiles into one visit, so patient selection discipline matters more than on either standalone device.
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.
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History3 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 7, 2026
patented tech
Source: Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)
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, "ilooda Fraxis Duo — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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