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510(k) Data Aggregation

    K Number
    K241229
    Device Name
    Hello,eyes® BIO Plug
    Manufacturer
    Bio Optics Co., Ltd.
    Date Cleared
    2024-06-28

    (57 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hello,eyes® BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and. - Determine the potential effectiveness of permanent occlusion.
    Device Description
    Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.
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    K Number
    K222164
    Device Name
    Visant Medical Canalicular Plug
    Manufacturer
    Visant Medical, Inc.
    Date Cleared
    2022-12-23

    (155 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
    Device Description
    The Visant Medical Canalicular Plug is designed to temporarily block tear drainage by the occlusion of the canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye. The Visant Plug consists of a transparent hydrogel, manufactured from cross-linked hyaluronic acid, that is designed for insertion into the canaliculus. The Visant Medical Canalicular Plug is inserted into the lower canaliculus of the patient's eyelid by the healthcare practitioner, using a commercially available lacrimal cannula attached to the 0.6 mL gel-filled syringe which pushes the gel into the lower punctum until the recommended volume of gel (0.2 mL) is inserted.
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    K Number
    K213988
    Device Name
    SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
    Manufacturer
    Oasis Medical, Inc
    Date Cleared
    2022-06-03

    (165 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and - Determine the potential effectiveness of permanent occlusion.
    Device Description
    The Oasis Medical SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug is a mid-term duration device designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from degradable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and have a base diameter of 0.6mm with one end tapered to enable easier placement through the punctal opening.
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    K Number
    K190210
    Device Name
    Tear Pool Dissolvable Punctum Plugs
    Manufacturer
    AlphaMed Inc
    Date Cleared
    2019-10-24

    (262 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system. Punctum Plugs are indicated for: - * As a diagnostic aid to determine the potential effectiveness of long term occlusion - * To temporarily enhance the efficacy of topical medications or ocular lubricants - * After ocular surgery to prevent complications due to dry eyes - * To evaluate treatment of ocular dryness - * To evaluate the dry eye component of ocular surface diseases
    Device Description
    The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye. This treatment is prescribed for temporary occlusion in the treatment of certain eye conditions collectively referred to as dry eye disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency. Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2. A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box. The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length Model# 20-5304 0.4mm Model# 20-5305 0.5mm The device is make from Polydioxanone(PDO). The plugs are violet in color.
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    K Number
    K162361
    Device Name
    Soft Plug Extended Duration 180 Canalicular Plug
    Manufacturer
    OASIS MEDICAL, INC.
    Date Cleared
    2017-04-17

    (237 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soft Plug® Extended Duration 180 Canalicular Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and - Determine the potential effectiveness of permanent occlusion.
    Device Description
    The OASIS Medical SOFT PLUG® Extended Duration 180 Canalicular Plug is a mid-term implant designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from absorbable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and available in 0.2mm, 0.3mm, 0.4mm, and 0.5mm diameters.
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    K Number
    K161673
    Device Name
    LacriPro Punctum Plug
    Manufacturer
    LACRIMEDICS, INC.
    Date Cleared
    2016-11-18

    (155 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LacriPro plugs may be used to: - Treat Dry Eye Syndrome - Treat ocular dryness secondary to contact lens use - Enhance the efficacy of topical ocular medications - Prevent complications due to dry eyes after surgery - Treat the Dry Eye component of ocular surface diseases
    Device Description
    The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the punctal opening (upper/lower) to restrict the natural lubricating tears from being pumped off the surface of the eye. This treatment is prescribed for long-term treatment of certain eye conditions collectively referred to as Dry Eye Disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency. LacriPro Punctum Plugs have a distal tip, a proximal cap and a body (tubular shaft) connecting the tip to the cap. The cap is designed to rest on the opening of the puncta after the tip and body are inserted into the canalicular canal. The cap has one or more recesses (depending on diameter) for retaining tear fluid. The plug has a passage extending in the distal direction from an opening in the proximal cap to facilitate mounting on an insertion tool. The LacriPro Punctum Plugs are available in the following models, diameters and lengths: Model # 1833 0.6mm (1.42mm length) x-small; Model # 1835 0.7mm (1.52mm length) Small; Model # 1837 0.8mm (1.60mm length) Medium; Model # 1839 0.9mm (1.78mm length) Large. The device is made from silicone liquid rubber MED 4870 by Nusil, Inc. The plugs are clear, or translucent.
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    K Number
    K150288
    Device Name
    PDO Absorbable Punctum Plug
    Manufacturer
    RIVERPOINT MEDICAL
    Date Cleared
    2015-08-28

    (204 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eye. The Absorbable Canalicular Plugs can be used in the treatment of dry eye following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a non-absorbable punctal occlusion device.
    Device Description
    The Riverpoint Medical PDO Absorbable Canalicular Plug is a monofilament synthetic absorbable device prepared from poly(p-dioxanone). PDO Absorbable Canalicular Plugs are available undyed or violet. When dyed, only FDA-approved color additives such as D&C Violet No. 2 are used. PDO Absorbable Canalicular Plugs are used to temporarily block tear drainage by the occlusion of the lacrimal canaliculi for approximately 180 days.
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    K Number
    K140352
    Device Name
    VERAPLUG
    Manufacturer
    KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
    Date Cleared
    2014-11-13

    (274 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
    Device Description
    The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter. The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
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    K Number
    K140711
    Device Name
    COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
    Manufacturer
    PARAGON BIOTECK, INC.
    Date Cleared
    2014-06-20

    (91 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Determine the potential effectiveness of permanent occlusion, . - Temporarily treat dry eye syndrome, and the dry eye components of various ocular . surface diseases, - . Temporarily enhance the efficacy of topical medications or ocular lubricants. - . Temporarily treat contact lens intolerance secondary to dry eye, and - Temporarily treat dry eye after ocular surgery.
    Device Description
    Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO). The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.
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    K Number
    K140026
    Device Name
    COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
    Manufacturer
    LACRIMEDICS, INC.
    Date Cleared
    2014-06-03

    (148 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).
    Device Description
    The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye. VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD). VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.
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