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510(k) Data Aggregation

    K Number
    K970475
    Device Name
    MM-RUBY
    Manufacturer
    AMERICAN LASERS, INC.
    Date Cleared
    1997-09-29

    (234 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 :

    MM-RUBY

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

    Q-SWITCHED MODE: FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS). LONG-PULSE MODE: FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS --LENTIGINES -- CAFE-AU-LAIT -- - - - - - --- EPHELDES never of OR -

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called MM-RUBY. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

    Therefore, I cannot fulfill your request for the specific information you asked for, as the provided input does not contain it. The letter focuses on regulatory clearance based on substantial equivalence, not on detailed performance study results or acceptance criteria.

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