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510(k) Data Aggregation

    K Number
    K240616
    Device Name
    FAQ™ (102)
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-07-15

    (132 days)

    Product Code
    PAY, NFO, OHS
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.
    Device Description
    Not Found
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    K Number
    K233766
    Device Name
    Geneo X Elite
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2024-05-07

    (165 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV. The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.
    Device Description
    The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation. The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator. In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.
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    K Number
    K232424
    Device Name
    CurrentBody Skin RF
    Manufacturer
    EL Global Trade Ltd.
    Date Cleared
    2024-03-06

    (208 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
    Device Description
    The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: User Interface, Programmable logic controller (PLC, microcontroller) embedded in PCBA, RF power module, Power Supply, RF electrodes. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
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    K Number
    K230013
    Device Name
    Silk'n Titan Allways
    Manufacturer
    Silk'n Beauty Ltd.
    Date Cleared
    2023-08-30

    (239 days)

    Product Code
    PAY, OHS
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.
    Device Description
    The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.
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    K Number
    K220322
    Device Name
    Pollogen STOP U Model UXV Device
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2023-05-04

    (455 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.
    Device Description
    The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.
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    K Number
    K222012
    Device Name
    FAQ 101
    Manufacturer
    Foreo, Inc.
    Date Cleared
    2023-04-05

    (271 days)

    Product Code
    PAY, OHS
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
    Device Description
    Not Found
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    K Number
    K202055
    Device Name
    Looper (Model: ZX-579S)
    Manufacturer
    Heat In A Click LLC
    Date Cleared
    2021-04-16

    (266 days)

    Product Code
    OLP, OHS
    Regulation Number
    878.4810
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne.
    Device Description
    Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode. Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from. Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment. The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device. There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.
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    K Number
    K203665
    Device Name
    STOP U Model UXV Device
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2021-02-25

    (71 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.
    Device Description
    The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.
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    K Number
    K182774
    Device Name
    STOP U (Packed Black USA), STOP U (Packed White USA)
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2019-06-19

    (261 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.
    Device Description
    The STOP U device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.
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    K Number
    K170499
    Device Name
    sensiLift
    Manufacturer
    EL GLOBAL TRADE LTD
    Date Cleared
    2017-06-15

    (118 days)

    Product Code
    PAY
    Regulation Number
    878.4420
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
    Device Description
    The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: - . User Interface - Programmable logic controller (PLC, microcontroller) embedded in PCBA ● - RF power module - Power Supply ● - RF electrodes ●
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