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510(k) Data Aggregation

    K Number
    K974142
    Device Name
    HM-RUBY
    Manufacturer
    AMERICAN LASERS, INC.
    Date Cleared
    1998-01-28

    (86 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 :

    HM-RUBY

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

    ALL 7A7700 FOR 02 (D) LIGHTENING RED I-xcEPT R TONIC 7-0 R JRZATMENT 1 151 FRIDERMAL PIGATENTED 0 L o 7 A NEVUS of FOR RZATMITENT (

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "HM-Ruby". It indicates that the device has been determined to be substantially equivalent to a predicate device and provides "Indications For Use". However, it does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions about the study that proves the device meets acceptance criteria. The document solely confirms regulatory clearance based on substantial equivalence, not a detailed performance study.

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