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    K Number
    K233872
    Device Name
    Daylight
    Manufacturer
    Big Health, Inc.
    Date Cleared
    2024-08-30

    (267 days)

    Product Code
    SCP, DAY
    Regulation Number
    882.5801
    Why did this record match?
    Product Code :

    SCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
    Device Description
    Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.
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