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510(k) Data Aggregation

    K Number
    K242389
    Device Name
    EyeGility™ Inserter for Preloaded enVista IOLs
    Manufacturer
    Bausch & Lomb Incorporated
    Date Cleared
    2024-10-10

    (59 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
    Device Description
    The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
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    K Number
    K231106
    Device Name
    Accuject Refra Injector AR2900
    Manufacturer
    Medicel AG
    Date Cleared
    2023-09-19

    (153 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye.
    Device Description
    The Medicel ACCUJECT™ REFRA Injector System, Model AR2900 is to be used by an ophthalmic surgeon and is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye. The ACCUJECTTM REFRA is a single use device designed specifically to deliver the STAAR Surgical Implantable Collamer® Lenses.
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    K Number
    K231838
    Device Name
    RxSight® Insertion Device (63002)
    Manufacturer
    RxSight, Inc.
    Date Cleared
    2023-08-15

    (54 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.
    Device Description
    The RxSight Insertion Device (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of: - A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge - A single-use, disposable, sterile haptic puller.
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    K Number
    K231466
    Device Name
    RxSight Insertion Device
    Manufacturer
    RxSight, Inc.
    Date Cleared
    2023-06-12

    (24 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
    Device Description
    The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
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    K Number
    K212039
    Device Name
    CLAREON MONARCH IV IOL Delivery System
    Manufacturer
    ALCON LABORATORIES, INC.
    Date Cleared
    2021-08-23

    (54 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLAREON MONARCH IV IOL Delivery System is for implantation of qualified Alcon foldable IOLs. No unqualified lenses should be used with the CLAREON MONARCH IV IOL Delivery System.
    Device Description
    The CLAREON MONARCH IV IOL Delivery System consists of two parts. An autoclavable, reusable, titanium handpiece and a sterile, single-use cartridge are used for implanting foldable intraocular lenses into the eye following removal of the natural crystalline lens. The system provides a controlled means to reliably place Alcon qualified intraocular lenses (IOLs) into the capsular bag when a qualified combination of handpiece, cartridge, Alcon foldable IOL, and ophthalmic viscosurgical device (OVD) is used. The cartridge is loaded by inserting the IOL into the opening in the back of cartridge after OVD is applied to the inner lumen of the cartridge. The loaded cartridge is installed into the handpiece and the IOL is delivered through the cartridge nozzle.
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    K Number
    K200057
    Device Name
    bioli lOL Delivery System
    Manufacturer
    AST Products, Inc.
    Date Cleared
    2020-06-04

    (143 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
    Device Description
    The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The bioli™ IOL Delivery System is intended for use during cataract surgery. The bioli™ IOL Delivery System is composed of two parts: - (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and - (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity. The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.
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    K Number
    K192926
    Device Name
    RxSight Insertion Device
    Manufacturer
    RxSight, Inc.
    Date Cleared
    2020-01-17

    (93 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
    Device Description
    The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
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    K Number
    K192005
    Device Name
    Bausch + Lomb PreVue Inserter for enVista Preloaded
    Manufacturer
    Bausch & Lomb, Inc
    Date Cleared
    2019-10-04

    (67 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
    Device Description
    The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile, single-use device used to fold and insert an intraocular lens (MX60PL) through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
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    K Number
    K191949
    Device Name
    UNFOLDER Vitan Inserter
    Manufacturer
    Johnson & Johnson Surgical Vision, Inc.
    Date Cleared
    2019-09-13

    (53 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.
    Device Description
    The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.
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    K Number
    K182965
    Device Name
    BL-Cart IOL Delivery Cartridge
    Manufacturer
    AST Products, Inc.
    Date Cleared
    2019-03-29

    (155 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    MSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartidge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
    Device Description
    BL-Cart™ IOL Delivery Cartridge (Model: Type D) is an intraocular lens (IOL) delivery cartridge solution capable of supplying the ophthalmologist surgeon with a cartridge pre-coated with lubricious coating for use during a typical cataract surgery. The BL-Cart™ cartridge is used to deliver an approved IOL lens. The BL-Cart™ IOL Delivery Cartridge and referenced predicate device, Monarch® III D cartridge, utilize the same lens folding system design in which IOLs are folded and/or delivered from an injector system and the resulting optical and physical properties of the IOL remain unchanged as a result of folding/delivery. The BL-Cart™ IOL Delivery Cartridge comes with one pre-coated cartridge, packaged in a Tyvek pouch, placed in a 10 unit box as intended for marketing, and sterilized by ethylene oxide (EtO). The BL-Cart™ IOL Delivery Cartridge and the referenced legally marketed predicate device share the same principal method to implant an intraocular lens into the eye.
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