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510(k) Data Aggregation

    K Number
    K111168
    Date Cleared
    2011-12-13

    (232 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    PRECISION SKIN EMULSION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Under the supervision of a healthcare professional, Precision Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Precision Skin Emulsion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

    Device Description

    Precision Skin Emulsion is a non-sterile, off-white, low odor, fragrance free, topical product. The Precision Skin Emulsion forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.

    AI/ML Overview

    I am sorry but I did not find any information about acceptance criteria or a study that proves the device meets the acceptance criteria. Thus, I cannot construct a response based on the request.

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