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

    LENS-PAC

    K Number: K813528 · Decision Jan 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    26

    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
    LENS-PAC
    K Number
    K813528
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    The Plactory
    Date Received
    December 17, 1981
    Decision Date
    January 12, 1982
    Product Code
    HPX
    Advisory Committee
    Unknown
    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
    HPX Lens, Contact (Polymethylmethacrylate)

    Similar 510(k) Clearances

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

    PMMA CLASIC

    FDA 510(k)
    FDA Unclassified ·Unknown

    KERATOPLASTY SUTURING LENS

    FDA 510(k)
    FDA Unclassified ·Unknown

    MULTI-VIEW BIFOCALS

    FDA 510(k)
    FDA Unclassified ·Unknown

    MARTIN-HENSLEY SEGMENT LENS

    FDA 510(k)
    FDA Unclassified ·Unknown

    OPTIKEM PMMA CONTACT LENS

    FDA 510(k)
    FDA Unclassified ·Unknown

    ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all