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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION DERMATOLOGY INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K111168
    Device Name
    PRECISION SKIN EMULSION
    Manufacturer
    PRECISION DERMATOLOGY INCORPORATED
    Date Cleared
    2011-12-13

    (232 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION DERMATOLOGY INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
    Ask a Question
    K Number
    K110727
    Device Name
    HYLATOPICPLUS CREAM
    Manufacturer
    PRECISION DERMATOLOGY INCORPORATED
    Date Cleared
    2011-04-01

    (16 days)

    Product Code
    FRO, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION DERMATOLOGY INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, HylatopicPlus™ Cream 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™ Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. HylatopicPlus™ Cream is indicated for use in: - Atopic Dermatitis - Allergic Contact Dermatitis - Radiation Dermatitis
    Device Description
    HylatopicPlus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. The HylatopicPlus forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.
    Ask a Question

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