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510(k) Data Aggregation

    K Number
    K983215
    Device Name
    MULTIPULSE CO2 LASER
    Manufacturer
    AESCULAP-MEDITEC GMBH
    Date Cleared
    1998-12-04

    (81 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 :

    MULTIPULSE CO2 LASER

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

    The Aesculap-Meditec CO2 Laser is intended for the ablation, vaporization, incision, excision, or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology.

    Device Description

    The Aesculap-Meditec MultiPulse-CO2 laser emits a beam of coherent light at 10.6 microns.

    AI/ML Overview

    The provided document is a 510(k) summary for the Aesculap-Meditec MultiPulse CO2 laser, not a study report detailing acceptance criteria and performance.

    The document explicitly states:

    "Performance Data: None. The specifications and indications for use of the Aesculap-Meditec MultiPulse CO2 laser are the same or very similar to those of the claimed predicate device. Because of this, performance data were not required."

    Therefore, based on the provided text, the device did not undergo a study to prove it meets specific acceptance criteria as it was determined to be substantially equivalent to a predicate device without requiring new performance data.

    Thus, I cannot provide the requested information from the given text.

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