BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DROLITE(TM) LIGHT SOURCE

    K Number: K913273 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    134

    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
    DROLITE(TM) LIGHT SOURCE
    K Number
    K913273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vision Medical, Inc.
    Date Received
    July 23, 1991
    Decision Date
    December 4, 1991
    Product Code
    HJM
    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
    HJM Transilluminator, Ac-Powered

    Similar 510(k) Clearances

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

    INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PEREGRINE DIFFUSION LIGHT PIPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PEREGRINE WIDE ANGLE LIGHT PIPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Vision Medical, Inc.

    K Number Device Name
    K913837 MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM