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

    EAGLEVISION GELLANSERTS, MODEL REF 0040

    K Number: K053333 · Decision May 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    38
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    152

    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
    EAGLEVISION GELLANSERTS, MODEL REF 0040
    K Number
    K053333
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eagle Vision, Inc.
    Date Received
    December 1, 2005
    Decision Date
    May 2, 2006
    Product Code
    LZU
    Advisory Committee
    Unknown
    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
    LZU Plug, Punctum

    Similar 510(k) Clearances

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

    Hello,eyes® BIO Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    Visant Medical Canalicular Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    Tear Pool Dissolvable Punctum Plugs

    FDA 510(k)
    FDA Unclassified ·Unknown

    Soft Plug Extended Duration 180 Canalicular Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    LacriPro Punctum Plug

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Eagle Vision, Inc.

    K Number Device Name
    K030353 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
    K991130 FLEXPLUG
    K905427 EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
    K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
    K890920 EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
    K883233 EV MONOCANALICULAR STENT (TM)