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510(k) Data Aggregation

    K Number
    K102375
    Device Name
    LUCIA
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2011-02-25

    (189 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
    Device Description
    The Lucia has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency, The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The Lucia generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.
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    K Number
    K081962
    Device Name
    LAPEX BCS
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2008-12-29

    (173 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAPEX BCS is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
    Device Description
    The LAPEX BCS has a hand-held treatment probe, is noninvasive, low level visible and infrared lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit. The LAPEX BCS generator operates automatic calculation of energy output in relation to set treatment parameters and the parameters(treatment time, output power delivered) can be adjusted by using key and treatment specifications and menus as well as treatment progressing are displayed on a LCD display in real time. And the LAPEX BCS generator operates simultaneous and independent management of outputs for connecting probes with laser sources of different wavelength. The LAPEX-BCS generator supplied with 2 completely independent outputs for using two treatment probes and simultaneously, even with laser sources of different wavelengths. The LCD displays operating parameters of both channels. 'This allows two operators to carry out laser therapy independently; just like having two separate instruments.
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    K Number
    K034009
    Device Name
    LAPEX 2000
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2005-01-21

    (394 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    The LAPEX-2000 is a low level laser therapy device.
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    K Number
    K023238
    Device Name
    MCPULSE
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2003-02-19

    (145 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.
    Device Description
    The McPulse Photo-Plethysmograph is intended to be used to measure pulse waveform and heart rate in the finger by lighting a fingertip with combination of infrared LED and photodiode. The measurement probe is an optoelectronic sensor consisted of a light-emitting diode(infrared LED) and a photodiode placed on opposite side as a light receiver. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on LCD screen. Pulse rate is measured using the time between successive pulses and displayed digital values on LCD screen. The McPulse system consists of an optoelectronic sensor that is applied to the patient and a microprocessor-based system that processes and displays the measurement. The optoelectronic sensor contains a light-emitting diode(infrared LED) and one photodiode as a light receiver. The light from the LED is transmitted through the tissue at the sensor site. The photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed.
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    K Number
    K020360
    Device Name
    ABR-2000
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2002-08-29

    (206 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABR-2000 intended use is for the meas orement of galvanic skin response.
    Device Description
    Not Found
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    K Number
    K010897
    Device Name
    MERIDIAN-PORTABLE
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2001-06-19

    (85 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001347
    Device Name
    MERIDIAN-II AND MERDIAN-PLUS
    Manufacturer
    MERIDIAN CO., LTD.
    Date Cleared
    2000-11-03

    (189 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIDIAN CO., LTD.

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

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