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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LZU FDA unclassified

    Plug, Punctum

    Unknown

    View full classification →

    The Punctum Plug (product code LZU) is a small device inserted into the lacrimal punctum (the small opening in the corner of the eyelid) to block drainage of tears, used in the treatment of dry eye syndrome by increasing tear film retention on the ocular surface. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ophthalmic (OP) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    Hello,eyes® BIO Plug
    Visant Medical Canalicular Plug
    SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
    Tear Pool Dissolvable Punctum Plugs
    Soft Plug Extended Duration 180 Canalicular Plug
    LacriPro Punctum Plug
    PDO Absorbable Punctum Plug
    VERAPLUG
    COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
    COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
    FLOW CONTROLLER
    SNUG PLUG PUNCTUM PLUG
    EAGLEVISION GELLANSERTS, MODEL REF 0040
    DELTA PUNCTUM PLUG
    HYDROGEL CANALICULAR PLUG
    INTELIPORT OCCLUDING DEVICE
    OPAQUE HERRICK LACRIMAL PLUG
    SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
    MOIST PUNCTAL PLUG SYSTEM
    SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
    OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
    SOFT PLUG ABSORBABLE PLUG-SA
    OCCU-FLO PUNCTUM PLUGS
    BIOINSULATED SILICONE PUNCTUM PLUG
    OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
    FLEXPLUG
    SURGIDEV SILICONE PUNCTUM PLUG
    SILICONE PUNCTAL PLUG
    PUNCTUAL OCCLUDER
    PUNCTUAL OCCLUDER
    HERRICK ULTIMATE PUNCTUM PLUG
    HERRICK ULTIMATE PUNCTUM PLUG
    PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
    READY-SET PUNCTAL PLUGS
    VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
    OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
    OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    COLLAGEN INTRACANALICULAR PLUG
    SILICONE PUNCTAL PLUG
    VISITEC CANALICULAR STENT
    EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
    OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
    LACRIMAL PLUG
    LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
    HERRICK LACRIMAL PLUG TM.
    COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
    LACRIMAL EFFICIENCY TEST (TM)
    TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
    EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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