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510(k) Data Aggregation

    K Number
    K110528
    Device Name
    INTEGRA LED SURGICAL HEADLIGHT SYSTEM
    Manufacturer
    INTEGRA LIFE SCIENCES CORPORATION
    Date Cleared
    2011-05-11

    (76 days)

    Product Code
    FSR
    Regulation Number
    886.4335
    Why did this record match?
    Product Code :

    FSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
    Device Description
    The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system. The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.
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    K Number
    K031548
    Device Name
    LED HEADLIGHT
    Manufacturer
    WELCH ALLYN, INC.
    Date Cleared
    2003-08-11

    (87 days)

    Product Code
    FSR
    Regulation Number
    886.4335
    Why did this record match?
    Product Code :

    FSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
    Device Description
    This product features an articulated projector that is mounted to a comfortable adjustable headband. The range of adjustability accommodates the majority of users. The actual source for the illumination is a high intensity white LED.
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    K Number
    K031549
    Device Name
    SOLID STATE LAMP [LED] HEADLIGHT
    Manufacturer
    WELCH ALLYN, INC.
    Date Cleared
    2003-08-11

    (87 days)

    Product Code
    FSR
    Regulation Number
    886.4335
    Why did this record match?
    Product Code :

    FSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
    Device Description
    This product consists of a light source that is held in place by a comfortable, adjustable and consumable Terrycloth headband with Velcro adjustments. The range of adjustability accommodates the majority of users. The portable Headlight is small, light weight and adjustable in both pointing direction and illuminated spot size.
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    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?
    Product Code :

    FSR

    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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