LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K013151
    Device Name
    ASMOTOM AUTOMATED TREPHINE SYSTEM
    Manufacturer
    BKG OPTHALMICS USA, INC.
    Date Cleared
    2001-12-14

    (85 days)

    Product Code
    HRG
    Regulation Number
    886.4070
    Why did this record match?
    Product Code :

    HRG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.
    Device Description
    Not Found
    Ask a Question
    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?
    Product Code :

    HRG

    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.
    Ask a Question

    Page 1 of 1