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510(k) Data Aggregation

    K Number
    K983984
    Device Name
    COOLTOUCH V ND:YAG
    Manufacturer
    LASER AESTHETICS, INC.
    Date Cleared
    1999-06-07

    (210 days)

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

    LASER AESTHETICS, INC.

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

    The Laser Aesthetics COOLTOUCH "V" Nd:YAG laser is indicated for use in surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue.

    Device Description

    The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical Laser is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the handpiece.

    AI/ML Overview

    The provided document is a 510(k) summary for the COOLTOUCH "V" Nd:YAG Surgical Laser. It explicitly states in the "Nonclinical Performance Data" and "Clinical Performance Data" sections that "None" were provided.

    Therefore, the device does not have any reported acceptance criteria or a study proving it meets them within this submission. The 510(k) approval is based on substantial equivalence to predicate devices, not on direct performance data from a specific study outlined here.

    Consequently, I cannot provide the requested information as it is not present in the provided text.

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