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510(k) Data Aggregation

    K Number
    K170489
    Device Name
    Skylit Phototherapy System
    Manufacturer
    Skylit Medical
    Date Cleared
    2017-05-23

    (95 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skylit Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
    Device Description
    The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories: - Handheld UV light Emission device that delivers the UVB light - Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders - Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
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