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510(k) Data Aggregation

    K Number
    K980187
    Device Name
    MLT R694 RUBY LASER SYSTEM
    Manufacturer
    MEDICAL LASER TECHNOLOGIES LTD.
    Date Cleared
    1998-04-03

    (73 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K990902
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MLT R694 Ruby Laser System is intended to remove unwanted body hair. Patient selection criteria include patients with skin types 1-4.

    Device Description

    The MLT R694 laser is a normal or long pulse ruby laser which emits a beam of coherent light at 694 nanometers.

    AI/ML Overview

    The provided text states that no performance data was required for the MLT R694 Ruby Laser System. The basis for this is that "The specifications and indications for use of the MLT R694 ruby system laser are the same or very similar to those of the claimed predicate devices."

    Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. No information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to specific performance criteria is provided, as these studies were deemed unnecessary due to substantial equivalence to predicate devices.

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