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510(k) Data Aggregation

    K Number
    K050216
    Device Name
    OMNILUX REVIVE AND OMNILUX PLUS
    Manufacturer
    PHOTO THERAPEUTICS LIMITED
    Date Cleared
    2005-08-09

    (190 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOTO THERAPEUTICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The Omnilux Revive and Omnilux Plus are two sources of high spectral purity. They provide uniform or "hot-spot" free illumination. The outputs are pre-tuned to one wavelength with a narrow spectral bandwidth. The output of the Omnilux Revive is 633 + 5 nm, and the output of the Ommilux Plus is 830 + 5 nm. The base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the ams and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control clectronics. The user interface software allows the operator to access and control all device functions.
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    K Number
    K043329
    Device Name
    OMNILUX REVIVE AND BLUE
    Manufacturer
    PHOTO THERAPEUTICS LIMITED
    Date Cleared
    2005-03-18

    (106 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOTO THERAPEUTICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
    Device Description
    The Omnilux Revive and Blue is a combination of two sources of high spectral purity. They provide uniform or "hot-spot" headwidth. The output pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. The Omnilux base unit contains the III I FD hose same attached to the end of the arms and then positioned for patient to the lesting. The user interface an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.
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    K Number
    K043317
    Device Name
    OMNILUX PLUS
    Manufacturer
    PHOTO THERAPEUTICS LIMITED
    Date Cleared
    2005-03-15

    (103 days)

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

    PHOTO THERAPEUTICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Plus is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and temporarily increase local blood circulation where applied.
    Device Description
    The Omnilux Plus is a near infra-red light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output wavelength is 830 ± 5 nm. The Omnilux Plus base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The user interface consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
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    K Number
    K030426
    Device Name
    OMNILUX RED
    Manufacturer
    PHOTO THERAPEUTICS LIMITED
    Date Cleared
    2003-07-17

    (157 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOTO THERAPEUTICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
    Device Description
    The Omnilux Revive is an intense visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 633 ± 5 nm. The Omnilux Revive base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
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    K Number
    K030883
    Device Name
    OMNILUX BLUE
    Manufacturer
    PHOTO THERAPEUTICS LIMITED
    Date Cleared
    2003-06-18

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOTO THERAPEUTICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The Omnilux Blue is a visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 415 + 5 nm. The Omnilux Blue base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
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