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

    POLAREX AND POLAREX MLD

    K Number: K863651 · Decision Oct 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    1
    Review Days
    22

    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
    POLAREX AND POLAREX MLD
    K Number
    K863651
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Selex, Inc.
    Date Received
    September 18, 1986
    Decision Date
    October 10, 1986
    Product Code
    HQY
    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
    HQY Sunglasses (Non-Prescription Including Photosensitive)

    Similar 510(k) Clearances

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

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MULTI

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