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510(k) Data Aggregation
K Number
K102375Device Name
LUCIA
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2011-02-25
(189 days)
Product Code
ILY
Regulation Number
890.5500Why 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
K081962Device Name
LAPEX BCS
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2008-12-29
(173 days)
Product Code
ILY
Regulation Number
890.5500Why 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
K034009Device Name
LAPEX 2000
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2005-01-21
(394 days)
Product Code
NHN
Regulation Number
890.5500Why 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
K023238Device Name
MCPULSE
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2003-02-19
(145 days)
Product Code
JOM
Regulation Number
870.2780Why 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
K020360Device Name
ABR-2000
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2002-08-29
(206 days)
Product Code
GZO
Regulation Number
882.1540Why 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
K010897Device Name
MERIDIAN-PORTABLE
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2001-06-19
(85 days)
Product Code
GZO
Regulation Number
882.1540Why 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
K001347Device Name
MERIDIAN-II AND MERDIAN-PLUS
Manufacturer
MERIDIAN CO., LTD.
Date Cleared
2000-11-03
(189 days)
Product Code
GZO
Regulation Number
882.1540Why 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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