BEUDAMED
    Product Code: ONO FDA class 2 21 CFR 878.4810

    Neurosurgical Laser With Mr Thermography

    General, Plastic Surgery

    The Neurosurgical Laser With MR Thermography (product code ONO) is a Class 2 surgical device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), reviewed by the Neurology panel and cleared via 510(k). It is used to necrotize or coagulate soft tissue through interstitial irradiation or laser thermal therapy under MRI guidance with real-time MR thermography during neurosurgical procedures. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    5
    Years Active
    4

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    Basic Information

    Product Code
    ONO
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K260976 NeuroBlate System
    K253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
    K251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
    K250307 Visualase V2 MRI-guided Laser Ablation System (9736422)
    K240877 Monteris Medical NeuroBlate System
    K214125 TRANBERG Thermoguide Therapy System
    K211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.