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510(k) Data Aggregation

    K Number
    K251298
    Device Name
    Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
    Manufacturer
    Clinical Laserthermia Systems AB
    Date Cleared
    2025-09-04

    (129 days)

    Product Code
    ONO
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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