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510(k) Data Aggregation

    K Number
    K121559
    Device Name
    HYLATOPICPLUS LOTION
    Manufacturer
    PRECISION DERMATOLOGY INCORPORATED
    Date Cleared
    2012-11-30

    (185 days)

    Product Code
    FRO,HYL
    Regulation Number
    N/A
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K110727
    Why did this record match?
    Device Name :

    HYLATOPICPLUS LOTION

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

    Under the supervision of a healthcare professional, HylatopicPlus Lotion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus Lotion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment. A moist wound & skin environment is known to be beneficial to the healing process.

    HylatopicPlus Lotion is indicated for use in:

    • Atopic Dermatitis
    • Allergic Contact Dermatitis
    • Radiation Dermatitis
    Device Description

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

    AI/ML Overview

    This document is a 510(k) Premarket Notification for HylatopicPlus® Lotion, seeking substantial equivalence to a previously cleared device (HylatopicPlus® Cream). It does not contain information on an AI/ML device or studies proving acceptance criteria for such a device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these concepts are not applicable to the provided document.

    The document focuses on demonstrating substantial equivalence of a topical lotion to a previously cleared cream based on their formulation, intended use, and manufacturing processes, not on performance metrics of an AI/ML system.

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