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510(k) Data Aggregation

    K Number
    K052680
    Device Name
    CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2006-01-23

    (117 days)

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

    The CALCULASE Holmium Laser System and Accessories are to be used by qualified surgeons in Urological Laser Lithotripsy stone therapy treatment. It is intended to be used in the fragmentation and vaporization of calculi stones in the urinary system (bladder, urethra, and kidney).

    Device Description

    Karl Storz CALCULASE Holmium Laser System is a Holmium Y AG Laser system operating at a wavelength of 2080 (2100) nm with impulse energy of 500-1700mJ and pulse frequency of 4-8Hz. The system is suitable for use in noninvasive and invasive Urological Lithotripsy stone therapy procedures.

    AI/ML Overview

    This document is a 510(k) summary for the Karl Storz CALCULASE Holmium Laser System and Accessories. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results showing device performance against such criteria.

    Therefore, I cannot provide the requested information. The document does not describe the acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria. It primarily asserts substantial equivalence based on similar technologies, designs, safety features, and intended uses to predicate devices.

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