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510(k) Data Aggregation

    K Number
    K251531

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-10-30

    (164 days)

    Product Code
    Regulation Number
    890.5650
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AIR COMPRESSION BOOTS is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas in people who are in good health. The AIR COMPRESSION BOOTS simulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    This product operates through an air pump stored internally, sending air into the air bag, inflating and deflating through the alternate work of the solenoid valve, and squeezing the leg to achieve a massage effect. This product consists of hand controller, air pump, air valve and leg bag. The following model numbers are identical in circuitry and electrical, mechanical and physical construction; the only differences are the size and model number for trading purpose. The model 1018196 is for the 26-inch size and model 1018195 is for the 32-inch size.

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    K Number
    K252093

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-10-16

    (105 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy.

    • Red light: Treatment of full-face wrinkles.
    • Blue light: Treatment of mild to moderate inflammatory acne.
    • Red+Infrared Light: Treatment of full-face wrinkles.
    • Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.
    Device Description

    The subject device Light Therapy 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-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

    The LEDs generate 3 kinds of light which include Red light (wavelength 635nm±5nm), Blue light (wavelength 465nm±5nm), Infrared light (wavelength 850nm±5nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device. And the straps used for securing the mask unit to the body part.

    The device have vibration function, and user can adjust the vibration intensity. Vibration is for general relaxation purposes.

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    K Number
    K252096

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-10-01

    (90 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is an over-the-counter device that is intended for use in the treatment of wrinkles in the decolletage area.

    Device Description

    The subject device LIGHT THERAPY DECOLLETE 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 cosmetic indications including facial wrinkles and acnes.

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

    The LEDs generate 2 kinds of light which include Red light (wavelength 630nm±5nm) and Infrared light (wavelength 850nm±5nm). A controller is connect to the decollete mask body unit to control the device, such as turn on/off the device. And the straps used for securing the decollete mask unit to the body part.

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