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    K Number
    K251781
    Device Name
    KALA MINI 2.0 (KALA-04)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2025-09-04

    (85 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K202390,K162763,K090008,K242151,K232977,K101716
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K202390, K162763, K090008

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KALA MINI 2.0 (Model: KALA-04) (Mode 1) 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.

    KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.

    Device Description

    The KALA MINI 2.0 (Model: KALA-04) is a home use light-emitting diode phototherapy device with four proven wavelengths of red light: 630nm, 660nm, and near infrared red light: 830nm, 850nm, the red light (630nm, 660nm) are known to treat the wrinkles and the NIR light (830nm, 850nm) to provide topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.

    The equipment is a panel that contains LEDs. There are two buttons, one LED display screen on this panel: the button used to control the treatment time and the irradiance of the device; the LED display screen will show the remaining treatment time. Beside the buttons, there are power indicator which will indicate the remaining battery power.

    There are fixed straps on the back of the panel, which you can use to hold the panel in your hand. The surfaces patients will contact with hand are constructed of silicone.

    The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA MINI 2.0 (Model: KALA-04) cannot be operated while charging. The cable for connecting with the controller is detachable.

    The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

    AI/ML Overview

    N/A

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