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510(k) Data Aggregation

    K Number
    K251973
    Device Name
    Luminance Red Cold Sore Device (TN1927G)
    Manufacturer
    Luminance Medical Ventures, Inc.
    Date Cleared
    2025-09-23

    (89 days)

    Product Code
    OKJ
    Regulation Number
    878.4860
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K222205
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Luminance Red Cold Sore device is indicated for shortening the time to healing of herpes simplex labialis lesions on and around the lips with time to healing defined as the time to patient described re-epithelialization.

    This device is suitable for users with Fitzpatrick skin types I-IV.

    Device Description

    The Luminance Red Cold Sore Device is a lightweight, hand held device that consists of a body handle and treatment head. The body handle contains LEDs that emit non-therapeutic visible red light and therapeutic invisible near-infrared light (1072 nm+/- 12 nm) through the treatment head. The non-therapeutic visible red light serves as a guidelight and is intended to enhance the usability of the device. The body consists of a plastic shell, which includes a button to turn the device on, a button to start treatment, and a digital countdown timer. The Luminance Red Cold Sore Device is powered by a lithium-ion battery.

    AI/ML Overview

    N/A

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