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510(k) Data Aggregation

    K Number
    K051816
    Device Name
    LUMIWAVE 1X4 INFRARED THERAPY DEVICE
    Manufacturer
    BIOCARE SYSTEMS, INC.
    Date Cleared
    2005-08-26

    (52 days)

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

    BIOCARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
    Device Description
    The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.
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    K Number
    K042532
    Device Name
    BIOCARE SYSTEMS PREMIR 818
    Manufacturer
    BIOCARE SYSTEMS, INC.
    Date Cleared
    2004-12-13

    (87 days)

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

    BIOCARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
    Device Description
    The PremIR 818 is an over-the-counter, infrared-therapy device, designed to emit energy at infe i reful o to is an over the osanton and one of the PremIR 818 provides infrared therapy through infrared frequencies to provide topical houng. In and that delivers infrared light for the purposes the use of an ennoicht und odor to acat living tissue in the body. Infrared light is delivered to the of elevating tissue tomporation to to a Arsenide (GaAlAs) Light Emitting Diodes (LEDs) distributed under the face plate of the PremIR 818. The LEDs used in the PremIR have average wavelengths of between 880 nm and 884 nm.
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