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510(k) Data Aggregation

    K Number
    K250776
    Device Name
    Lithoblast Single Use Holmium Laser Fibers
    Manufacturer
    Dawell Medical LLC.
    Date Cleared
    2025-10-14

    (214 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K170366
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.

    Device Description

    The LithoBlast Single-Use Holmium Laser Fibers are single use surgical fiberoptic laser delivery devices that transmit laser energy in a forward direction. The devices include a SMA 905 connector at the proximal end. The laser fibers are compatible with Ho:YAG laser systems. There are four (4) fiber core diameters: 272 Series (272 µm), 365 Series (365 µm), 550 Series (550 µm), and 940 Series (940 µm).

    The laser fibers in the LithoBlast family are 300cm long. All have a 10 mm straight cut flat cleaved distal end. All include a stress booth and an ABS over nut extension sleeve (type A=straight and narrow; type B=indented with finger grips; type C=finger grips protrude) to enable the operator's firm grip. The SMA-905 connector attaches at the proximal end of the device.

    AI/ML Overview

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