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510(k) Data Aggregation

    K Number
    K153164
    Device Name
    LunulaLaser
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2016-06-03

    (214 days)

    Product Code
    PDZ
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LunulaLaser

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

    The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomyosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the LunulaLaser, a Class II medical device. It does not provide information on acceptance criteria or a study that proves the device meets those criteria. Instead, it confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indication of temporary increase of clear nail in patients with onychomycosis.

    Therefore, I cannot extract the requested information based on the provided text. The document is administrative in nature, approving the device for marketing based on substantial equivalence, rather than detailing a performance study with acceptance criteria.

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