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Cynosure Lutronic eCO2 3D

CO2 Fractional/Ablative · CO2 fractional resurfacing laser

Technology: CO2 Fractional Laser

Classification & configurations

Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)

Current

At a glance

New price
Not published
FDA status

Record scope: 510(k): K244060 (decision 31 Jul 2025). Checked 4 Sep 2026.

Supplies & recurring costs
Supply details not yet documented.
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Sources and data on file

Data on file

Recurring consumables
Not verified
FDA
FDA record cited — see scopeK244060
Used asking prices
Not verified
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Figures are reference points, not current offers.

Read FDA-cleared indicationsExact wording from 1 FDA record

K244060 (Lutronic Corporation, 2025)

The eCO2 3D Laser System with fractional handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry. Dermatology & Plastic Surgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * Laser skin resurfacing * Treatment of wrinkles, rhytids and furrows * Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement. Dermatology. Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Podiatry: Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

Page updated: October 1, 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
Key facts
ManufacturerCynosure Lutronic
CompanyOwner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct
Parent companyCynosure Lutronic
Brand ownerCynosure Lutronic
Built by (OEM)Cynosure LLC
CategoryCO2 Fractional/Ablative
TechnologyCO2 fractional resurfacing laser
FDA statusFDA record cited — see scope
510(k) citationK244060
New price rangeNot published
Used price referenceNot published
ConsumablesNot published
Launch yearNot published
PricingNot published
Manufacturer-source documents checkedNot published

Overview

eCO2 3D is a Cynosure Lutronic fractional CO2 laser system. It provides adjustable resurfacing delivery with different spot sizes and treatment modes.

Recovery and treatment intensity depend on the settings, treatment area and patient.

FDA & regulatory detailClearance timeline, authorization route and citation notes
Authorized via 510(k)

510(k): K244060 (decision 31 Jul 2025). Checked 4 Sep 2026.

FDA-cleared indications (verbatim)

K244060 (Lutronic Corporation, 2025)

The eCO2 3D Laser System with fractional handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry. Dermatology & Plastic Surgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * Laser skin resurfacing * Treatment of wrinkles, rhytids and furrows * Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement. Dermatology. Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Podiatry: Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

Marketed for

CO2 fractional — CO2 fractional resurfacing laser

Marketing claims are the manufacturer's own and are not the same as a cleared indication.

Parent company: Cynosure Lutronic

Legal manufacturer: Cynosure LLC (United States)

Applicant on the FDA record

Lutronic CorporationThe 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.

Treatment & running costs

Treatment and running-cost details aren’t documented yet.

Ask the supplier for the session schedule, supplies per treatment and annual service costs.

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Current alternatives

Current catalog models to research. Confirm availability and configuration with the supplier.

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History6 tracked changes

Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.

  1. October 1, 2026

    Sourced profile overview

    Added a neutral overview from the linked manufacturer or official US distributor source. This is field-specific sourcing, not verification of every other profile field.

    Source: https://www.cynosure.com/product/eco2-3d/

  2. September 4, 2026

    FDA status

    Unknown → Cleared

    Clearance located on openFDA

    Source: Council round 2 audit, verified on openFDA 2026-09-04

  3. September 4, 2026

    FDA status

    Unknown → Cleared

    Source: Catalog update

  4. September 4, 2026

    510(k) numbers

    K-number set re-verified against openFDA

    Source: Council round 2 audit, verified on openFDA 2026-09-04

  5. September 4, 2026

    FDA K-numbers

    Source: Catalog update

  6. September 4, 2026

    FDA source URL

    Source: Catalog update

Cite this data: The Aesthetic Index, "Cynosure Lutronic eCO2 3D — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).

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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. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.