Search Results
Found 7 results
510(k) Data Aggregation
K Number
K102945Device Name
PEDIACYN ATOPIC DERMATITIS HYDROGEL
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2011-02-02
(121 days)
Product Code
FRO
Regulation Number
N/AWhy 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.
Ask a Question
K Number
K093585Device Name
MICROCYN SKIN AND WOUND HYDROGEL
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2010-03-08
(109 days)
Product Code
FRO
Regulation Number
N/AWhy 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.
Ask a Question
K Number
K090206Device 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/AWhy 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.
Ask a Question
K Number
K090725Device Name
OCULUS MICROCYN WOUND GEL
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2009-05-20
(62 days)
Product Code
FRO
Regulation Number
N/AWhy 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
Ask a Question
K Number
K060113Device Name
DERMACYN WOUND CARE
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2006-02-22
(36 days)
Product Code
FRO
Regulation Number
N/AWhy 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.
Ask a Question
K Number
K042729Device Name
DERMACYN WOUND IRRIGATION
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2005-05-17
(228 days)
Product Code
FRO
Regulation Number
N/AWhy 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.
Ask a Question
K Number
K041161Device Name
MICROCYN WOUND CARE DRESSING
Manufacturer
OCULUS INNOVATIVE SCIENCES, INC.
Date Cleared
2005-05-03
(365 days)
Product Code
FRO
Regulation Number
N/AWhy 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.
Ask a Question
Page 1 of 1