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510(k) Data Aggregation

    K Number
    K242747
    Device Name
    FAQ™ (302)
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-12-11

    (90 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foreo Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface. By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds. The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off. The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.
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    K Number
    K241102
    Device Name
    Luna 4 plus
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-08-20

    (120 days)

    Product Code
    OHS, NFO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foreo Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles
    Device Description
    Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction. The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles. Microcurrent to target facial stimulation. Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software. Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons. Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foreo Inc.

    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
    K232242
    Device Name
    BEAR 2 Body
    Manufacturer
    FOREO Inc.
    Date Cleared
    2024-05-13

    (290 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREO Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
    Device Description
    Not Found
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    K Number
    K240378
    Device Name
    FAQ™ 201, FAQ™ 202
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-04-19

    (72 days)

    Product Code
    OHS, OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foreo Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FAO™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.
    Device Description
    Not Found
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    K Number
    K231977
    Device Name
    PEACH 2, PEACH 2 Duo, PEACH 2 go
    Manufacturer
    Foreo Inc.
    Date Cleared
    2023-09-25

    (84 days)

    Product Code
    OHT, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foreo Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
    Device Description
    Not Found
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    K Number
    K162450
    Device Name
    ESPADA Acne-Clearing Blue Light Pen
    Manufacturer
    FOREO INC.
    Date Cleared
    2016-11-30

    (90 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
    Device Description
    Not Found
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