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510(k) Data Aggregation

    K Number
    K073404
    Device Name
    IFS LASER SYSTEM
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2008-04-25

    (143 days)

    Product Code
    GEX, HNO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iFS Laser System is an ophthalmic surgical laser indicated for use: - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments - In lamellar keratoplasty and corneal harvesting - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
    Device Description
    The iFS Laser System is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use: - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea: - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; - In lamellar keratoplasty and corneal harvesting; - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the . creation of a penetrating cut/incision for penetrating keratoplasty. Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
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    K Number
    K063682
    Device Name
    INTRALASE FUSION LASER
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2007-02-09

    (60 days)

    Product Code
    GEX, HNO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The IntraLase Fusion Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase Fusion Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
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    K Number
    K041893
    Device Name
    INTRALASE FS LASER
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2005-07-29

    (381 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use: - In patients undergoing surgery or other treatment requiring intial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of the corneal ring segments - In lamellar keratoplasty and corneal harvesting - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
    Device Description
    The INTRALASE FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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    K Number
    K031960
    Device Name
    INTRALASE FS LASER
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2003-09-29

    (96 days)

    Product Code
    GEX, HNO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTRALASE® FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LA'SIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The INTRALASE FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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    K Number
    K013941
    Device Name
    PULSION FS LASER KERATOME
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2002-02-27

    (90 days)

    Product Code
    GEX, HNO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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    K Number
    K002890
    Device Name
    INTRALASE 600C LASER KERATOME
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2001-08-09

    (328 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001211
    Device Name
    MODIFICATION TO INTRALASE 600C LASER KERATOME
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    2000-12-04

    (234 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993153
    Device Name
    INTRALASE 600C LASER KERATOME
    Manufacturer
    INTRALASE CORP.
    Date Cleared
    1999-12-17

    (87 days)

    Product Code
    GEX, HNO
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRALASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The IntraLase 600C Laser Keratome is a precision ophthalmic surgical laser designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing anterior lamellar corneal resections. The materials, basic scientific concepts and physical properties of the IntraLase 600C are similar to those of the ISL OC2000, while the indication for use and the intended use are identical to those of the Hansatome microkeratome.
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