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510(k) Data Aggregation

    K Number
    K041212
    Device Name
    HOUVA 3 PHOTOTHERAPY SYSTEM
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Date Cleared
    2004-06-09

    (30 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOUVA 3 PHOTOTHERAPY SYSTEM

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

    The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for a phototherapy system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed scientific study demonstrating the device meets performance metrics.

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