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510(k) Data Aggregation

    K Number
    K162578
    Device Name
    Zerona Z6 OTC
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2016-12-16

    (92 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K220519,K231474
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Zerona Z6 OTC device. It does not contain information about acceptance criteria, device performance, or study details.

    Therefore, I cannot provide the requested information. The letter only confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated use.

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