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Found 16 results
510(k) Data Aggregation
K Number
K162217Device Name
LOYON
Manufacturer
Oculus Innovative Sciences
Date Cleared
2017-03-23
(227 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Oculus Innovative Sciences
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.
Device Description
LOYON® is a non-sterile, oily solution, exclusively indicated for topical application. LOYON® is used to manage and relieve burning and itching and scaling experienced with various types of dermatoses. It will be supplied in 15mL or 50mL amber glass bottles with a pump sprayer.
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K Number
K161034Device Name
Microcyn Plus Wound Care Solution
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2016-08-19
(128 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications: Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.
Device Description
The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.
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K Number
K153648Device Name
Microcyn Plus Skin and Wound Hydrogel
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2016-04-19
(120 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indications for Use:
Under the supervision of a health care professional Microcyn Plus Skin and Wound Gel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Plus Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
OTC Indications for Use:
Microcyn Plus Skin and Wound Gel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Plus Skin and Wound Gel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
Device Description
The Microcyn Plus Skin and Wound Hydrogel is a clear gel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of 12,000-20,000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
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K Number
K152945Device Name
Alevicyn SG Antipruritic Gel
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2015-12-15
(70 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indication: Under the supervision of a health care professional, Alevicyn SG Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and sebortheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Device Description
The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.
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K Number
K152055Device Name
Ceramax Skin Barrier Cream
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2015-11-23
(122 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Device Description
Ceramax emollient formulation is a non-sterile, off-white, low odor, fragrance free, topical formulation delivers as a cream or a foam. The cream is dispensed via a tube and rubbed into the skin. When the Ceramax formulation is applied to diseased skin protective barrier that helps to maintain a moist wound and skin environment is formed. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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K Number
K143590Device Name
Alevicyn SG Antipruritic Gel
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2015-06-04
(168 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment. which is beneficial to the healing process.
OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.
Device Description
The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screwtop closure and a finger pump sprayer.
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K Number
K141352Device Name
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2014-08-18
(87 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.
Device Description
The Endocyn Root Canal Irrigation Solution is a colorless, slightly chlorinated odor, clear aqueous solution intended to irrigate, cleanse, and debride root canal systems. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure.
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K Number
K141012Device Name
HYDROCLEANSE WOUND CARE SOLUTION
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2014-08-08
(109 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indications: Under the supervision of a healthcare professional, Hydrocleanse™ Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second- degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is als intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications: OTC Hydrocleanse™ Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Device Description
The Oculus Hydrocleanse Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.
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K Number
K131672Device Name
MICROCYN SCAR MANAGEMENT HYDROGEL
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2013-11-15
(162 days)
Product Code
PFP
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
OCULUS INNOVATIVE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Device Description
Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the
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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.
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