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510(k) Data Aggregation

    K Number
    K130996
    Device Name
    ERCHONIA EMERGE
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2013-09-16

    (159 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ERCHONIA EMERGE

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

    The Erchonia® XLR8™ laser is indicated for the following three indications:

    • a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
    • b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
    • c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Erchonia XLR8TM laser, indicating its intended uses based on substantial equivalence to existing devices. It does not contain information about acceptance criteria or specific study data proving the device meets those criteria. The provided text is a regulatory clearance document, not a detailed study report. Therefore, I cannot extract the requested information from this document.

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