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510(k) Data Aggregation

    K Number
    K252568

    Validate with FDA (Live)

    Device Name
    New Day Skin Spray
    Manufacturer
    Silk Holdings, Inc.
    Date Cleared
    2026-01-23

    (162 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K052643
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    New Day Skin Spray is a skin emulsion indicated for the management of dryness of skin, and atopic dermatitis. New Day Skin Spray maintains a moist skin and wound environment beneficial to the healing process.

    Device Description

    The New Day Skin Spray is a skin emulsion designed to manage atopic dermatitis. A thin layer is to be applied to the affected area for up to 28 days or until symptoms subside. The applied thin layer of New Day Skin Spray forms a breathable layer by maintaining a moist wound and skin environment, which is beneficial to the healing process.

    AI/ML Overview

    N/A

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