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510(k) Data Aggregation

    K Number
    K253391

    Validate with FDA (Live)

    Device Name
    Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
    Manufacturer
    Medtronic Navigation, Inc.
    Date Cleared
    2026-03-13

    (164 days)

    Product Code
    ONO
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    Neurology
    Age Range
    2 - 120
    Reference & Predicate Devices
    K211269,K250307
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K211269, K250307

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Visualase™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers.

    The Visualase™ V2 MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

    Device Description

    The Visualase Cooled Laser Applicator System (VCLAS) is an MR-compatible (conditional), sterile, single-use, saline-cooled laser applicator with proprietary diffusing tips that deliver controlled energy to targeted tissue when connected to the Visualase Systems.

    The VCLAS is an accessory to both cleared versions of the Visualase Cooled Laser Ablation Systems - Visualase MRI-guided Laser Ablation System (V1 System, K211269) and Visualase V2 MRI-guided Laser Ablation System (V2 System, K250307). The V1 and V2 systems are not subjects of this submission.

    This change encompasses changes to the Visualase Cooled Laser Applicator System (VCLAS) pump tubing set, extension tubing and inlet/outlet ports to ensure compatibility with both cleared Visualase Systems (K211269 and K250307) and accompanying information to inform safe and effective use. The device modifications include material changes and there are no changes to Visualase Systems (V1 and V2 system)' hardware or software.

    AI/ML Overview

    N/A

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