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

    ULTRATHIN/SP LENS

    K Number: K843957 · Decision Jul 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    294

    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
    ULTRATHIN/SP LENS
    K Number
    K843957
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Optical Systems Intl., Inc.
    Date Received
    October 10, 1984
    Decision Date
    July 31, 1985
    Product Code
    HRG
    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
    HRG Engine, Trephine, Accessories, Ac-Powered

    Similar 510(k) Clearances

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

    ASMOTOM AUTOMATED TREPHINE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    AUTOMATED CORNEAL TREPHINE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SCANLAN VASCU-STATT II

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TREPHINE BLADES-VARIOUS MODELS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    (MICRO-KERATRON, MICRO DUCT TREPHINE)

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

    Other Clearances by Optical Systems Intl., Inc.

    K Number Device Name
    K854218 THE ULTRA-MATE LENS