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510(k) Data Aggregation
K Number
K082969Device Name
LUMINEX INFRARED LAMP SYSTEM
Manufacturer
Date Cleared
2008-10-23
(17 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SYSTEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Luminex Infrared Lamp System is intended to emit energy in the visible and near 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 Luminex Infrared Lamp System is an AC operated, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared and visible laser diodes. The system consists of a Control Unit that houses the electronics and controls, and treatment probes that contain the infrared and visible laser diodes. The probes are intended to be placed directly on the skin to provide topical heating.
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K Number
K063574Device Name
LUMINEX LL LASER SYSTEM
Manufacturer
Date Cleared
2007-01-29
(61 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL LASER SYSTEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome
Device Description
The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.
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