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510(k) Data Aggregation

    K Number
    K252142

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (150 days)

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

    Multi-functional Facial Beauty Device (model: SKB-1909):

    • Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
    • Red light is intended for the treatment of facial wrinkles.

    Multi-functional Facial Beauty Device (model: SKB-1703):

    • Blue light is intended for the treatment of facial mild to moderate inflammatory acne.

    Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):

    • Red light is intended for the treatment of facial wrinkles.
    Device Description

    The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

    The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.

    a. Micro-current stimulation function.
    b. Red LED irradiation function.
    c. Blue LED irradiation.
    d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress (39℃±0.5℃) is not for medical purpose).
    e. Hot compress function.(The hot compress (35.5℃~38.5±0.5℃) is not for medical purpose).
    f. Vibration function.(The vibration is classified as class I and not need for 510K).

    Each mode of the Multi-functional Facial Beauty Device is independent from all other modes of the device.

    AI/ML Overview

    N/A

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