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510(k) Data Aggregation

    K Number
    K102945
    Device Name
    PEDIACYN ATOPIC DERMATITIS HYDROGEL
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2011-02-02

    (121 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a health care professional, Epicyn HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Epicyn HydroGel may be also used to relieve the pain of first and second degree burns. Epicyn HydroGel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    Epicyn™ HydroGel is an emollient containing, non oily pH neutral hydrogel. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching associated with various types of dermatoses including atopic dermatitis. The gel will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) tamper resistant snap-top closure as described in Section 11.3.
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    K Number
    K093585
    Device Name
    MICROCYN SKIN AND WOUND HYDROGEL
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2010-03-08

    (109 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and painrelief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
    Device Description
    Microcyn™ Skin and Wound HydroGel is a clear viscous, odoriess, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene, tamper resistant caps as described in Section 11.3.
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    K Number
    K090206
    Device Name
    OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2009-06-02

    (125 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions. lacerations, minor irritations. cuts, and intact skin. Professional Use: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management via debridement of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
    Device Description
    Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is a clear hypotonic solution that aids in the mechanical removal of the debris and foreign material from the application site. Dirt debris and foreign material are mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). The device also contains antimicrobial agents that inhibit the growth of microorganisms. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing inserts and caps as described in Section 11.3.
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    K Number
    K090725
    Device Name
    OCULUS MICROCYN WOUND GEL
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2009-05-20

    (62 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Oculus Microcyn™ Skin and Wound Gel is intended for over the counter use for minor skin abrasions, lacerations, minor irritations and intact skin. Professional Use: Under the supervision of a healthcare professional, Oculus Microcyn™ Skin and Wound Gel is intended for exuding wounds such as leg ulcers, pressure ulcer, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
    Device Description
    Oculus Microcyn™ Skin and Wound Gel is a clear viscous, odorless, aqueous hydrogel. The gel will be supplied in 2 oz polyethylene terephthalate bottles with polypropylene disc top caps as described in Section 11.3
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    K Number
    K060113
    Device Name
    DERMACYN WOUND CARE
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2006-02-22

    (36 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermacyn™ Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin. Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
    Device Description
    The subject device is a wound cleansing solution that is intended for the moistening and debriding of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The subject device is offered in various bottle sizes with and without a trigger spray.
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    K Number
    K042729
    Device Name
    DERMACYN WOUND IRRIGATION
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2005-05-17

    (228 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermacyn™ Wound Cleanser is intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
    Device Description
    The subject device is a wound cleansing solution that is intended for the cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The subject device is offered in various bottle sizes.
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    K Number
    K041161
    Device Name
    MICROCYN WOUND CARE DRESSING
    Manufacturer
    OCULUS INNOVATIVE SCIENCES, INC.
    Date Cleared
    2005-05-03

    (365 days)

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

    OCULUS INNOVATIVE SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.
    Device Description
    The subject device is an 8 ounce polyethylene bottle containing Dermacyn™ Wound Care Dressing intended for multi-use.
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