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

    ACC CROSS CYLINDERS

    K Number: K852056 · Decision Jun 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    27

    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
    ACC CROSS CYLINDERS
    K Number
    K852056
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1405
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ascon Medical Instruments, Ltd.
    Date Received
    May 9, 1985
    Decision Date
    June 5, 1985
    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

    Similar 510(k) Clearances

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

    BOBES LENS SET

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OTI MODEL TLS-60

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTHALMIC TRIAL LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CONTACT LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MARCO TRIAL SETS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BURTON TRIAL LENS SET

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

    Other Clearances by Ascon Medical Instruments, Ltd.

    K Number Device Name
    K852054 CONTACT LENS LOUPE, INSPETION LOUPE
    K852055 ASCON OPHTHALMIC SPONGE
    K852548 ATL 225 MW TRAIL LENS SET
    K852057 ASCON SURGICAL INSTRUMENTS
    K852126 ATF 101 TRAIL FRAME