BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OCULAR CONFORMER

    K Number: K970319 · Decision Jul 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    160

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OCULAR CONFORMER
    K Number
    K970319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3130
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xavier A. Guerra, Ocularist, Inc.
    Date Received
    January 28, 1997
    Decision Date
    July 7, 1997
    Product Code
    HQN
    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
    HQN Conformer, Ophthalmic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQN), ordered by most recent decision date.

    MEDPOR OCULAR CONFORMER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OCULAR CONFORMER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KOLBERG OPHTHALMIC CONFORMER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STERILE/SINGLE USE SYMBLEPHARON RING

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STERILE/SINGLE USE OPHTHALMIC CONFORMERS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MOLDEYE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Xavier A. Guerra, Ocularist, Inc.

    K Number Device Name
    K970320 SCLERAL SHELL