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
Record scope: K160312 (Fraxis Duo; decision 2016-10-28): fractional CO2 mode is indicated only for ablative skin resurfacing; non-fractional CO2 mode is indicated for the stated incision, excision, ablation, vaporization and coagulation of body soft tissues; HF electrosurgical part is intended for electro-coagulation and hemostasis in dermatologic and general surgical procedures. The two systems cannot be used simultaneously.
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeK160312
- 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 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: October 6, 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 |
|---|---|
| Company | Owner: Bain Capital, via Classys Inc. (absorbed 2025) (subsidiary, since 2023) · Distribution: hybrid (direct + distributor) |
| Parent company | CLASSYS |
| Brand owner | ilooda |
| Built by (OEM) | Ilooda Co., Ltd. |
| Category | CO2 Fractional/Ablative |
| Technology | Fractional CO2 + RF microneedling |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K160312 |
| New price range | $60k–$90k |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | 2017 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Company source
·Manufacturer-provided · Updated Oct 6, 2026CLASSYS reports a 2024 merger with Ilooda. Historical legal manufacturer/applicant remains Ilooda; distribution is a separate role. FDA: FDA documentOverview
Fraxis Duo is an Ilooda system combining a CO2 laser with a high-frequency electrosurgical system; the FDA submission describes them as separate systems that cannot be used simultaneously. The CO2 source operates at 10,600 nm and has fractional and non-fractional handpiece modes.
The HF component delivers energy through disposable micro-needle electrodes. FDA-cleared use under K160312 is limited to fractional-mode ablative skin resurfacing, specified non-fractional CO2 soft-tissue procedures, and HF electro-coagulation and hemostasis in dermatologic and general surgical procedures.
Verify the quoted configuration, included handpieces, electrode supply, service arrangements, and applicable labeling with the seller before purchase.
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
Source and verification notes
·FDA database · Updated Oct 6, 2026Record-specific FDA scope reviewed October 6, 2026. K160312 (Fraxis Duo; decision 2016-10-28): fractional CO2 mode is indicated only for ablative skin resurfacing; non-fractional CO2 mode is indicated for the stated incision, excision, ablation, vaporization and coagulation of body soft tissues; HF electrosurgical part is intended for electro-coagulation and hemostasis in dermatologic and general surgical procedures. The two systems cannot be used simultaneously. Other records:Clearance 2016 · Launch 2017 · K160312
K160312 (Fraxis Duo; decision 2016-10-28): fractional CO2 mode is indicated only for ablative skin resurfacing; non-fractional CO2 mode is indicated for the stated incision, excision, ablation, vaporization and coagulation of body soft tissues; HF electrosurgical part is intended for electro-coagulation and hemostasis in dermatologic and general surgical procedures. The two systems cannot be used simultaneously.
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.
Parent company: CLASSYS
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
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: 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. 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
FDA K160312 documents disposable micro-needle electrodes for the RF handpiece. Current electrode pricing, compatibility and supply require confirmation for the exact configuration; the record does not establish aftermarket interchangeability or ongoing laser service costs.
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 ilooda Fraxis Duo. Published figures appear where available; review them before using the estimate.
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Your estimate
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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
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.
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.
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Current alternatives
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History8 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 6, 2026
manufacturer attribution council batch 01 evidence
Claim-specific evidence; not a whole-profile verification.
Source: https://classys.com/company/classys/
October 6, 2026
FDA indication
Source: Catalog update
October 6, 2026
FDA source URL
https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160312.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/pdf16/K160312.pdf
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
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 November 3, 2026).
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