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510(k) Data Aggregation

    K Number
    K981235
    Device Name
    OCULOSTAT
    Manufacturer
    LASER CENTER DEV. CORP.
    Date Cleared
    1998-07-15

    (103 days)

    Product Code
    HNC
    Regulation Number
    886.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER CENTER DEV. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.
    Device Description
    The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
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    K Number
    K981063
    Device Name
    AUTOMATED CORNEAL TREPHINE
    Manufacturer
    LASER CENTER DEV. CORP.
    Date Cleared
    1998-06-23

    (92 days)

    Product Code
    HRG
    Regulation Number
    886.4070
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER CENTER DEV. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.
    Device Description
    The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made of medical grade injection-molded plastic and stainless steel. The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. This trephine features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation. The blade depth is preset at the factory so that the extent of penetration is very precise.
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