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510(k) Data Aggregation

    K Number
    K234085
    Device Name
    LUNE™ PureHygiene
    Manufacturer
    Enamel Pure
    Date Cleared
    2024-03-25

    (94 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K221761,K193486
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K221761

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

    Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:
    • Reduction of bacterial level (decontamination)

    Device Description

    The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.

    AI/ML Overview

    The provided text does not contain detailed information about acceptance criteria for a device, nor does it describe a study that proves a device meets specific acceptance criteria in the manner requested.

    The document is an FDA 510(k) clearance letter for the LUNE™ PureHygiene dental laser system. It states that the device is substantially equivalent to a predicate device (Epic Pro/Hygiene Biolase). The "Summary of Performance Data (Nonclinical and/or Clinical)" section on page 5 lists non-clinical tests performed (Electrical Safety, EMC, Laser Safety, Software V&V, Design Verification, Reprocessing Validation, Biocompatibility Assessment) but explicitly states "N/A" for "Clinical Tests."

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no clinical study or specific performance acceptance criteria are detailed in this document.

    The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, supported by non-clinical testing.

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