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510(k) Data Aggregation

    K Number
    K982940
    Device Name
    LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
    Manufacturer
    STAR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-04-08

    (230 days)

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

    STAR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
    Device Description
    The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The handpiece tip is water-cooled to provide active skin cooling.
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    K Number
    K974346
    Device Name
    STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
    Manufacturer
    STAR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-01-16

    (58 days)

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

    STAR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
    Device Description
    The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
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    K Number
    K973324
    Device Name
    STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
    Manufacturer
    STAR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-12-03

    (90 days)

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

    STAR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.
    Device Description
    The StarLight™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
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    K Number
    K960625
    Device Name
    SPREADABLE SHEATH INTRODUCER SET
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-08-08

    (177 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOSTAR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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