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510(k) Data Aggregation

    K Number
    K122848
    Device Name
    LENSTEC LC INJECTION SYSTEM
    Manufacturer
    LENSTEC, INC.
    Date Cleared
    2013-10-18

    (395 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction.
    Device Description
    The system consists of the following components: Cartridge with silicone cushion, IOL, Injector. One type of injector is provided: it is syringe based and is reusable and autoclavable. One type of lens loader is provided, which is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile. The system has three major components: a reusable injector, a reusable lens loader and one of three disposable cartridges (LC 16, LC 1620, LC 2420) with a silicone cushion (SIC-01-02). a. the injector is manufactured of titanium and can be autoclaved. b. the lens loader is manufactured from plastic and can be autoclaved. c. the cartridge is manufactured of medical grade polypropylene and is for single use. d. the silicone tip is manufactured of medical grade silicone and is for single use.
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    K Number
    K091915
    Device Name
    FLUID ISOLATION DEVICE
    Manufacturer
    LENSTEC, INC.
    Date Cleared
    2009-10-27

    (119 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lenstec Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells
    Device Description
    The Fluid Isolation Device (FID) is a medical device which is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. The system consists of the following components: Vacuum ring suction cup connected to lure lock with silicone tubing, 20 mL Vaclok Syringe. Following cataract extraction, the device's vacuum ring suction cup is placed onto the posterior surface of the anterior capsule, and a seal is created by the user drawing back the handle of the Vaclok Syringe. Once the seal is created, the user irrigates the capsule of residual cortex and/or epithelial cells. The device is provided sterile (ethylene oxide).
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    K Number
    K063802
    Device Name
    LENSTEC LC INJECTION SYSTEM
    Manufacturer
    LENSTEC, INC.
    Date Cleared
    2007-05-07

    (136 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.
    Device Description
    The system consists of the following components: Cartridge (LC-16 w/ Silicone Cushion (SIC-01-02) or LC-24 w/ Silicone Cushion (SIC-01-02)) and Injector (I-9011). One type of injector is provided: it is syringe based and is reusable and autoclavable. The cartridges/silicone cushion is single-use and provided sterile.
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    K Number
    K060533
    Device Name
    LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
    Manufacturer
    LENSTEC, INC.
    Date Cleared
    2006-04-14

    (45 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lenstec IOL Injection System is intended for use in implantation of the Lenstec Softec Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
    Device Description
    The system consists of the following components: Cartridge LC604220 used with Injector I 9000 for Nominal Incision Size (mm) 2.8 and Used with Softec Intraocular Lenses Power Range (D) 26.5D to 42.0D; Cartridge LC604240 W/LS604500 used with Injector I 9007 for Nominal Incision Size (mm) 2.2 and Used with Softec Intraocular Lenses Power Range (D) -5.0D to 26.0D. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
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    K Number
    K050638
    Device Name
    LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
    Manufacturer
    LENSTEC, INC.
    Date Cleared
    2005-05-31

    (81 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LENSTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lenstec IOL Injection System if intended for use in implantation of the Lenstec Tetraflex™ Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
    Device Description
    The system consists of the following components: Cartridge, Injector. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
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