BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OTI MODEL TLS-60

    K Number: K951437 · Decision Apr 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    OTI MODEL TLS-60
    K Number
    K951437
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1405
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oti Medical, LLC
    Date Received
    March 27, 1995
    Decision Date
    April 11, 1995
    Product Code
    HPC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HPC Set, Lens, Trial, Ophthalmic

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    Other Clearances by Oti Medical, LLC

    K Number Device Name
    K951184 OTI MODEL 78-60