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510(k) Data Aggregation

    K Number
    K252745

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (105 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Halo Sterile Single-use Radial Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Halo Sterile Single-use Radial Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

    Device Description

    The Halo Sterile Single - use Radial Fibers (Model: Halo - R - 0.40 - 2.5/Halo - R - 0.60 - 2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8), as surgical laser fibers, are suitable for use in combination with commercially available diode laser systems with a wavelength ranging from500nm to 2200nm and equipped with SMA905 connectors. The output power should not exceed 30 W. This device is single use only and sterilized by EO gas.The Halo Sterile Single - use Radial Fibers are intended for general surgical operations such as incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissues in either contact or non - contact mode. In particular, they are designed for endovascular coagulation of blood vessels.The Fiber is radial-typed fiber. The shape of distal end of fiber is conical to radiate laser radially.

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