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510(k) Data Aggregation

    K Number
    K090078
    Device Name
    KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
    Manufacturer
    IOP, INC.
    Date Cleared
    2009-05-08

    (116 days)

    Product Code
    NXM
    Regulation Number
    886.3130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
    Device Description
    The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm
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    K Number
    K062252
    Device Name
    MOLTENO3
    Manufacturer
    IOP, INC.
    Date Cleared
    2006-09-27

    (55 days)

    Product Code
    KYF, REG
    Regulation Number
    886.3920
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular The Molten.> Elawoma where medical and conventional surgical treatments have not been successful to control the progression of disease.
    Device Description
    The Molteno3 Glaucoma implant consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. This third generation design is intended to maximize single quadrant bleb performance and simplify insertion and postoperative management.
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    K Number
    K053622
    Device Name
    SURGISIS OCULAR GRAFT
    Manufacturer
    IOP, INC.
    Date Cleared
    2006-03-15

    (77 days)

    Product Code
    NXM
    Regulation Number
    886.3130
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid. The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
    Device Description
    The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
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    K Number
    K010852
    Device Name
    OSMED TISSUE EXPANDER
    Manufacturer
    IOP, INC.
    Date Cleared
    2001-08-13

    (145 days)

    Product Code
    NFM
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003646
    Device Name
    SUTUREGROOVE WEIGHT SIZING SET
    Manufacturer
    IOP, INC.
    Date Cleared
    2001-02-22

    (87 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994289
    Device Name
    SUTUREGROOVE
    Manufacturer
    IOP, INC.
    Date Cleared
    2000-04-17

    (118 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis
    Device Description
    Not Found
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    K Number
    K972143
    Device Name
    MOA BONE / M-SPHERE
    Manufacturer
    IOP, INC.
    Date Cleared
    1997-10-16

    (132 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydroxyapitate orbital implants are indicated for post enucleation patients. This product is intended to establish a platform to affix an artificial eye that becomes integrated with the patients tissues.
    Device Description
    Moa Bone™ - Hydroxyapitate Orbital Implant
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