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510(k) Data Aggregation

    K Number
    K112131
    Device Name
    NEODYNE DRESSING
    Manufacturer
    NEODYNE BIOSCIENCES, INC.
    Date Cleared
    2011-09-29

    (65 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
    Device Description
    The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.
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    K Number
    K111733
    Device Name
    CORELEADER SCAR-DIMMER
    Manufacturer
    CORELEADER BIOTECH CO., LTD.
    Date Cleared
    2011-09-22

    (93 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.
    Device Description
    Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.
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    K Number
    K083718
    Device Name
    BEAU RX SCAR CARE GEL
    Manufacturer
    BEAU RX SOLUTIONS, LLC.
    Date Cleared
    2009-01-26

    (42 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Beau RX™ Scar Care Gel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds
    Device Description
    Beau RxTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over-the-counter use It is applied topically to aid in the management of both old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds
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    K Number
    K053481
    Device Name
    KELO-COTE SPRAY
    Manufacturer
    ADVANCED BIO-TECHNOLOGIES, INC.
    Date Cleared
    2006-04-14

    (121 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kelo-Cote Spray is a topical silicone spray 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
    Kelo-Cote Spray is a lightweight, self-drying silicone gel spray for the treatment of scars. Upon drying, the silicone gel layer forms a film for the management of scars. The components of Kelo-Cote Spray include fumed silica and silicone elastomer, liquid, and gum. It is provided in a can with a spray nozzle for application purposes.
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    K Number
    K041704
    Device Name
    NEWGEL AND NEWGEL PLUS E
    Manufacturer
    NEWMEDICAL TECHNOLOGY, INC.
    Date Cleared
    2005-10-17

    (481 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of hypertrophic and keloid scars
    Device Description
    The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.
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    K Number
    K040307
    Device Name
    HANSON SCAR ADE
    Manufacturer
    HANSON MEDICAL, INC.
    Date Cleared
    2004-08-12

    (185 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars
    Device Description
    HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in managing would and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.
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    K Number
    K024057
    Device Name
    CURAD SCAR THERAPY
    Manufacturer
    BEIERSDORF, INC.
    Date Cleared
    2003-06-18

    (191 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.
    Device Description
    Curad® Scar Therapy is a semi-occlusive, flexible pad for the management of hypertrophic scars resulting from burns, surgery, or injuries, after complete healing. The device is also intended for management of keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring. It is intended for over-the-counter use. Curad® Scar Therapy consists of an adhesive aliphatic polyurethane matrix. Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a waterproof polyurethane film that is permeable to oxygen and water vapor. The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.
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    K Number
    K024160
    Device Name
    NEOSPORIN SCAR SOLUTION
    Manufacturer
    WARNER-LAMBERT CO.
    Date Cleared
    2003-03-17

    (90 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
    Device Description
    [Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of the product is a proprietary material called Silon®. The basic Silon material is made from a blend of medical grade silicone and polytetrafluoroethylene ("PTFE") in the form of an interpenetrating polymer network. [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar.
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    K Number
    K023678
    Device Name
    DIMISIL SCAR GEL
    Manufacturer
    AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
    Date Cleared
    2003-01-23

    (83 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
    Device Description
    The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.
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    K Number
    K023136
    Device Name
    OLEEVA FABRIC
    Manufacturer
    BIO MED SCIENCES, INC.
    Date Cleared
    2002-10-16

    (26 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    MDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
    Device Description
    Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.
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