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510(k) Data Aggregation

    K Number
    K031954
    Device Name
    COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2003-08-21

    (57 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 :

    COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS

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

    The CoolTouch CT3 ND:YAG Laser System is indicated for treatment of back acne and treatment of atrophic acne scars

    Device Description

    The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasers are lasers producing emissions at 1320nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the CoolTouch CT3 laser systems, focusing on its substantial equivalence to a predicate device for specific indications (treatment of back acne and atrophic acne scars). It mentions compliance with certain CFR sections but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.

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