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510(k) Data Aggregation

    K Number
    K994010
    Device Name
    INNOVAQUARTZ GENERAL SHAPE LASER FIBER
    Manufacturer
    INNOVAQUARTZ
    Date Cleared
    1999-12-17

    (21 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INNOVAQUARTZ GENERAL SHAPE LASER FIBER

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

    The InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, coagulation, hemostasis and incision of soft tissue. It is designed for use with ND: Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

    Device Description

    InnovaQuartz General Shape Laser Fiber

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the InnovaQuartz General Shape Laser Fiber (K994010). It states that the device is substantially equivalent to a predicate device but does not contain any information regarding specific acceptance criteria, device performance, or study details.

    Therefore, I cannot provide the requested information. The document is a regulatory approval, not a technical report on device performance testing.

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