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510(k) Data Aggregation

    K Number
    K251843
    Device Name
    Erchonia EVRL
    Manufacturer
    Erchonia Corporation
    Date Cleared
    2025-09-12

    (88 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K220729,K160691
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Erchonia EVRL is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.

    Device Description

    The Erchonia EVRL is a compact, handheld device designed to reduce the appearance of mild to moderate acne. It emits visible blue light at a 405nm wavelength and red light at 640nm, both with a ±10nm tolerance.

    The EVRL device provides a non-thermal and non-contact treatment, designed for use approximately one to three inches from the skin without direct contact. It features an intuitive touchscreen interface with a preset acne treatment protocol, activated by a press-to-start button for ease of operation. A built-in visual countdown timer and audible treatment indicator "beep" assist the user during treatment, and the device automatically powers off upon completion of the treatment cycle. The wavelength and power settings are factory-set and cannot be modified by the user.

    The Erchonia EVRL has been classified by the FDA as a Class II device. The testing of the Erchonia EVRL device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement. The software incorporated into the operation of the Erchonia EVRL complies with FDA and ISO Software Development and Validation regulations.

    AI/ML Overview

    N/A

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