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

    SPECTACLE PRESCRIPTION LENSES

    K Number: K853110 · Decision Aug 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    602
    Registration Numbers
    602
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    16

    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 PRESCRIPTION LENSES
    K Number
    K853110
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ancie Laboratories
    Date Received
    July 24, 1985
    Decision Date
    August 9, 1985
    Product Code
    HQG
    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
    HQG Lens, Spectacle, Non-Custom (Prescription)

    Similar 510(k) Clearances

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

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SEIKO P-6 PROGRESSIVE SPECTACLE LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NEOLENS PRESCRIPTION SPECTACLE LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CR-39 PLASTIC LENSES FOR EYEGLASSES

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