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510(k) Data Aggregation

    K Number
    K132940
    Device Name
    ERCHONIA ALLAY
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2014-04-14

    (207 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K180197,K190572
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

    Device Description

    Erchonia Allay

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "Erchonia Allay", an infrared lamp indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

    However, the document is a regulatory approval letter and does not contain the acceptance criteria or any study details that would demonstrate the device meets such criteria. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual study report submitted by Erchonia Medical, Inc. to the FDA as part of their 510(k) submission (K132940).

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