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510(k) Data Aggregation

    K Number
    K250482
    Device Name
    Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
    Manufacturer
    Fissiontech LLC
    Date Cleared
    2025-05-08

    (78 days)

    Product Code
    LRK, LQZ
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fissiontech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
    Device Description
    The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
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    K Number
    K233850
    Device Name
    Difiney Anti Snoring Device
    Manufacturer
    Fissiontech LLC
    Date Cleared
    2024-04-18

    (135 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fissiontech LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.
    Device Description
    The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.
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