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510(k) Data Aggregation

    K Number
    K243875
    Device Name
    Spectricept Skin and Wound Cleanser
    Manufacturer
    Spectrum Antimicrobials, Inc.
    Date Cleared
    2025-04-21

    (125 days)

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

    Spectrum Antimicrobials, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    **Spectricept Skin and Wound Cleanser for Professional Use:** Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. **Spectricept Skin and Wound Cleanser for OTC Use:** Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.
    Device Description
    Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze). Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use. Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.
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    K Number
    K213514
    Device Name
    Spectricept Skin and Wound Cleanser
    Manufacturer
    Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
    Date Cleared
    2023-01-13

    (437 days)

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

    Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spectricept Skin and Wound Cleanser for Professional Use: Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. Spectricept Skin and Wound Cleanser for OTC Use: Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, moistening, debridement and removal of foreign material including debris from of skin abrasions, minor irritations, cuts and intact skin.
    Device Description
    Spectricent Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze). Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
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