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510(k) Data Aggregation

    K Number
    K970319
    Device Name
    OCULAR CONFORMER
    Manufacturer
    XAVIER A. GUERRA, OCULARIST, INC.
    Date Cleared
    1997-07-07

    (160 days)

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

    XAVIER A. GUERRA, OCULARIST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration 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, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.
    Device Description
    Not Found
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    K Number
    K970320
    Device Name
    SCLERAL SHELL
    Manufacturer
    XAVIER A. GUERRA, OCULARIST, INC.
    Date Cleared
    1997-07-07

    (160 days)

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

    XAVIER A. GUERRA, OCULARIST, 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
    SCLERAL SHELL, an ocular prosthesis, (artificial eye)
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