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510(k) Data Aggregation

    K Number
    K082089
    Device Name
    PRUMYX CREAM
    Manufacturer
    PRUGEN, INC.
    Date Cleared
    2009-01-13

    (173 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041342
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRUGEN, INC.

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

    FOR TOPICAL DERMATOLOGICAL USE ONLY

    Description Rx Product:
    Under the supervision of a healthcare professional, PruMyx Cream is indicated to manage and relieve the burning and itching experienced with various-types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. PruMyx Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

    Description OTC Product:
    PruMyx Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. PruMyx Cream may also be used to soothe minor bums, including sunburn.

    Device Description

    PruMyx™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.

    AI/ML Overview

    This document refers to PruMyx™ Cream, a medical device. There is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the provided text.

    The document is a 510(k) premarket notification for a medical device (PruMyx™ Cream) and a letter from the FDA determining substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and study results.

    The key points from the provided text are:

    • Substantial Equivalence: PruMyx™ Cream is deemed substantially equivalent to MimyX® Cream (cleared under K041342).
    • Intended Use: The device is for topical application to manage and relieve burning and itching associated with various dermatoses (prescription use) and to nourish skin and relieve burning/itching from common skin irritation and minor burns (OTC use).
    • Safety and Efficacy: The summary states, "Functional and performance testing has been conducted to assess the safety and efficacy PruMyx™ Cream and results are satisfactory," but no details of this testing are provided.

    Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text.

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