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510(k) Data Aggregation

    K Number
    K143351
    Device Name
    iCase Contact Lens Case
    Manufacturer
    Novabay Pharmaceuticals, Inc
    Date Cleared
    2015-04-29

    (156 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novabay Pharmaceuticals, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.
    Device Description
    The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.
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    K Number
    K131542
    Device Name
    NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
    Manufacturer
    Novabay Pharmaceuticals, Inc
    Date Cleared
    2013-07-24

    (56 days)

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

    Novabay Pharmaceuticals, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
    Device Description
    NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution. The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.
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    K Number
    K113820
    Device Name
    NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
    Manufacturer
    NOVABAY PHARMACEUTICALS
    Date Cleared
    2012-08-08

    (225 days)

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

    NOVABAY PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
    Device Description
    NeutroPhase Skin and Wound Cleanser is a clear, liquid solution cleanser and wound dressing that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the skin and wound cleanser moving across the wound bed. The product is composed of HOCl 0.01% in saline. The antimicrobial agent inhibits the growth of microorganisms in solution.
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    K Number
    K081009
    Device Name
    NEUTROPHASE
    Manufacturer
    NOVABAY PHARMACEUTICALS
    Date Cleared
    2008-05-20

    (42 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVABAY PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
    Device Description
    NeutroPhase is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The device is offered in various bottle sizes.
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    K Number
    K071056
    Device Name
    NEUTROPHASE WOUND CLEANSER
    Manufacturer
    NOVABAY PHARMACEUTICALS
    Date Cleared
    2007-09-28

    (165 days)

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

    NOVABAY PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
    Device Description
    NeutroPhase™ is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris.
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