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510(k) Data Aggregation

    K Number
    K994362
    Device Name
    HEADLAMP HL2000.
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    2000-05-11

    (136 days)

    Product Code
    FSR
    Regulation Number
    886.4335
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headlamp HL2000 has indicated use in the following situations: There is a requirement for illuminating a surgical field. . · There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
    Device Description
    The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
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    K Number
    K992447
    Device Name
    50 W METAL HALIDE ILLUMINATOR, VES 0501.
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1999-10-20

    (90 days)

    Product Code
    FCW, FCR, FFS, GCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 50 W Metal Halide Illuminator has indicated use in the following situations: - There is a requirement for illuminating medical headlamps. - There is a requirement for fiber-optic illumination for endoscopy applications. - There is a requirement to use video as a visual aid or a method of recording or both. - There is a requirement for any or all of the above at the same time.
    Device Description
    Not Found
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    K Number
    K982397
    Device Name
    VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-09-10

    (63 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
    Device Description
    Not Found
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    K Number
    K982409
    Device Name
    VES 1501-M
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-08-21

    (42 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
    Device Description
    Not Found
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    K Number
    K981819
    Device Name
    ANGIOLAZ VES-1CAM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-08-04

    (74 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.
    Device Description
    Not Found
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    K Number
    K981821
    Device Name
    VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-07-29

    (68 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 3001/w use is indicated in the following situations: - Whenever there is a need for head lamp illumination of the fiber-optic type . - When ever there is a need for a fiber-optic illuminator for an endoscope . - . When ever there is a need to use video either as a visual aid for as a method of recording or both. - When ever there is a requirement for any or all of the above at the same . time.
    Device Description
    Not Found
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    K Number
    K981827
    Device Name
    VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-07-28

    (67 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLAZ, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.
    Device Description
    The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages: - Longer life (150 hours vs. typically 40 hours). - Low energy at the light guide end virtually eliminating problems with burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.) - 3400% color temperature. - Better utilization of the available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle. The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords. The fully assembled system meets the current UL544 current leakage requirements. The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.
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