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510(k) Data Aggregation

    K Number
    K000544
    Device Name
    BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
    Manufacturer
    LABTICIAN OPHTHALMICS, INC.
    Date Cleared
    2000-03-09

    (20 days)

    Product Code
    HJX
    Regulation Number
    886.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABTICIAN OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990224
    Device Name
    LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
    Manufacturer
    LABTICIAN OPHTHALMICS, INC.
    Date Cleared
    1999-04-12

    (77 days)

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

    LABTICIAN OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos. Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead. The corresponding implantable gold eyelid weight is then prescribed for implantation. Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
    Device Description
    Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive. The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted. Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.
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    K Number
    K983607
    Device Name
    LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
    Manufacturer
    LABTICIAN OPHTHALMICS, INC.
    Date Cleared
    1999-01-08

    (86 days)

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

    LABTICIAN OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Labtician Lid Load Gold Eyelid Weight Implants, surgically implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. Functional defects which may be corrected or avoided with the use of Labtician lid Load Gold Eyelid Weight Implants include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
    Device Description
    The Labtician Lid Load Gold Eyelid Weight Implants are spherically radiused strips of pure gold (99.99%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. All product specifications are substantially equivalent to the predicate device, the Series 3000 Gold Evelid Implant, produced by MedDev Corporation, with the exception that Labtician Lid Load Gold Eyelid Weight Implants are supplied sterile, whereas the predicate device is supplied nonsterile and designed to be sterilized prior to surgery by the end user. Labtician Lid Load Gold Evelid Weight Implants are constructed of pure gold (99.99%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. Suture holes are placed in the implant to allow the surgeon to secure it to the tarsus or orbital septum.
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