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510(k) Data Aggregation

    K Number
    K253874

    Validate with FDA (Live)

    Device Name
    LED Therapy Light (COB1400, HP1800PRO)
    Manufacturer
    Shenzhen Hanhua Opto Co., Ltd.
    Date Cleared
    2026-03-03

    (89 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K223544,K212275,K171323
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LED Therapy Light is an over-the-counter (OTC) device intended for the following uses:

    For Red Mode: The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.

    For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

    For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.

    Device Description

    The LED Therapy Light employs dual-spectrum LEDs that emit red and near-infrared light, allowing simultaneous delivery of both wavelengths for synergistic treatment effects.

    AI/ML Overview

    N/A

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