BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    SPECTACLE FRAME OR EYEGLASS FRAMES

    K Number: K945176 · Decision Dec 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1086
    Registration Numbers
    1086
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    52

    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
    SPECTACLE FRAME OR EYEGLASS FRAMES
    K Number
    K945176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optipia Trading Co.
    Date Received
    October 24, 1994
    Decision Date
    December 15, 1994
    Product Code
    HQZ
    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
    HQZ Frame, Spectacle

    Similar 510(k) Clearances

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

    VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SPECTACLE FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SPECTACLE FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPTICAL FRAMES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FRAME, SPECTACLES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MAG-1 SPECTACLE FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all