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510(k) Data Aggregation

    K Number
    K252218
    Device Name
    MF SC GEN2 Facial Toning System
    Manufacturer
    Micro Current Technology, Inc.
    Date Cleared
    2025-07-18

    (3 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K244004
    Device Name
    Microcurrent Facial Device (CEC101, EE0101, EEI101)
    Manufacturer
    Shenzhen Dachi communication Co.,Ltd.
    Date Cleared
    2025-07-10

    (196 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250361
    Device Name
    SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
    Manufacturer
    GESKE Beauty Tech GmbH
    Date Cleared
    2025-05-23

    (102 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
    Device Description
    SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
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    K Number
    K243072
    Device Name
    Préime DermaFacial (MicroT)
    Manufacturer
    EMA Aesthetics, LTD
    Date Cleared
    2025-04-01

    (186 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.
    Device Description
    Not Found
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    K Number
    K243587
    Device Name
    PureLift GLOW
    Manufacturer
    Xtreem Pulse LLC
    Date Cleared
    2025-03-06

    (106 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
    Device Description
    PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne. The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths. The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.
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    K Number
    K243063
    Device Name
    Myolight Microcurrent Handpiece
    Manufacturer
    Raja Trading Company, Inc.
    Date Cleared
    2025-02-10

    (136 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
    Device Description
    The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
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    K Number
    K243393
    Device Name
    JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-02-03

    (95 days)

    Product Code
    NFO, OHS
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use. JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.
    Device Description
    Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle. The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.
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    K Number
    K244048
    Device Name
    Medi Lift Mask
    Manufacturer
    YA-MAN Ltd
    Date Cleared
    2025-01-16

    (16 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
    Device Description
    The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
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    K Number
    K243430
    Device Name
    Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
    Manufacturer
    Shenzhen Aozemei Technology Co. Ltd
    Date Cleared
    2024-12-19

    (44 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
    Device Description
    The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base 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 two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions: a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718) b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718) c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.
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    K Number
    K242532
    Device Name
    BTL-785BNF-E
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2024-12-13

    (109 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for aesthetic use including facial and neck or body skin stimulation.
    Device Description
    The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use. The main control unit is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, the remaining therapy time and the main therapy parameters on the screen. The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face. The device consists of the following main components: BTL-785 main unit, BTL-785-7 Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.
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