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510(k) Data Aggregation

    K Number
    K081307
    Device Name
    OMNILUX CLEAR-U
    Manufacturer
    PHOTO THERAPEUTICS, INC.
    Date Cleared
    2009-01-16

    (253 days)

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

    PHOTO THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
    Device Description
    The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
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    K Number
    K072459
    Device Name
    OMNILUX NEW-U
    Manufacturer
    PHOTO THERAPEUTICS, INC.
    Date Cleared
    2008-03-03

    (185 days)

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

    PHOTO THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles. The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The Omnilux New-U is a source of high spectral purity. It provides uniform or "hot-spot" free illumination. The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. The red output of the Omnilux New-U is 633 + 6 nm, and the IR output is 830 ± 5 nm. The Omnilux New-U device itself contains a selector switch (red/off/IR), the LED array assembly, and arrangements for air cooling. A separate, universal, power supply converts mains AC power to the DC power required by the Omnilux New-U. Treatment time is controlled by the operator.
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