Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252146

    Validate with FDA (Live)

    Date Cleared
    2025-12-23

    (167 days)

    Product Code
    Regulation Number
    882.5890
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K252142

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

    Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode.

    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. (Cleared under K252142).
    c. Blue LED irradiation.(Cleared under K252142).
    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(motor vibration).(The vibration is classified as class I and not need for 510K).

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

    The Multi-functional Facial Beauty Device consists of a main unit, USB charging cable, components shown as following illustration: (Here takes model SKB-2109 and model SKB-2129 as examples)

    SKB-2109:

    • Intensity indicator
    • Mode indicator
    • Intensity button
    • OFF/ON& Mode switch button
    • Massage head
    • LED light
    • Massage head
    • USB charging cable

    SKB-2129:

    • LEDs (Red)
    • Massage head
    • Power/Mode/Intensity Button
    • RED LIGHT Indicator
    • MC Indicator
    • Intensity Indicator
    • USB charging cable
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1