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510(k) Data Aggregation

    K Number
    K253400

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
    Manufacturer
    Shenzhen Saidi Light Therapy Technology Co., Ltd.
    Date Cleared
    2025-12-24

    (85 days)

    Product Code
    OHS,ILY,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K120775,K192295,K223544
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    a. Red light: Treatment of full-face wrinkles.
    b. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness, promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    c. Amber light: Treatment of full-face wrinkles.
    d. Blue light: Treatment of mild to moderate inflammatory acne.

    Device Description

    The subject device LED LIGHT THERAPY FACE MASK is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes.

    The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

    The LEDs generate 4 kinds of light which include 460nm±5nm blue light, 630±5nm and 660nm±5nm red light, 850±5nm near-infrared light, 605±5nm amber light. A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED mode output. And the straps used for securing the mask unit to the body part.

    AI/ML Overview

    N/A

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