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510(k) Data Aggregation

    K Number
    K972002
    Device Name
    CYNOSURE DERMATOLOGY LASER COOLING TIP
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    1997-08-27

    (89 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 Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the CYNOSURE Dermatology Laser Cooling Tip. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data, clinical study results, or information on how the device's efficacy or safety was evaluated in terms of specific metrics.

    Therefore, I cannot provide the requested information based on the provided text.

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