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510(k) Data Aggregation

    K Number
    K970318
    Device Name
    OCULAR CONFORMER
    Manufacturer
    SOUTHWEST ARTIFICIAL EYES, INC.
    Date Cleared
    1997-07-07

    (160 days)

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

    SOUTHWEST ARTIFICIAL EYES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.
    Device Description
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    K Number
    K970327
    Device Name
    SCLERAL SHELL
    Manufacturer
    SOUTHWEST ARTIFICIAL EYES, INC.
    Date Cleared
    1997-07-07

    (160 days)

    Product Code
    HQT
    Regulation Number
    886.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUTHWEST ARTIFICIAL EYES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities. In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.
    Device Description
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