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510(k) Data Aggregation
K Number
K132016Device Name
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
Manufacturer
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
Date Cleared
2014-06-02
(336 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are intended to emit energy in the 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
Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are laser therapy devices for applications suitable to be used in an ambulatory setting and under the care of a licensed healthcare provider. In particular the device works by providing infrared energy to elevate tissue temperature.
The Lumix 3 series laser therapy heat lamp heat devices deliver visible and invisible laser light at the wavelength of 910 nm (pulsed infrared), 808nm (continuous and interrupted infrared) and 650nm (continuous red visible). The pulsed laser sources used are of diodic type for pulsed working mode; the continuous laser sources used are of diodic type for continuous and frequenced working mode.
The laser light beam produced by the diode is carried to the focusing lens optic fibers with very low attenuation and high mechanical strength. The laser light, produced by the different sources, is emitted in a single bright beam, which at the optical unit output has a diameter equal to at 20mm. The flexible arm can be oriented by the user at will to heat-treat the required tissue area.
The optical unit contains a focusing lens with a high transmission coefficient used to focus the light beam carried by the optical fibers on the tissue to be treated. In order to identify precisely the tissue area to be irradiated, it is important to have a guide light available (650nm red) with a beam collimated with the laser light beam. The guide light allows one to visualize the target site clearly. The red quide light has no therapeutic value.
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