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510(k) Data Aggregation

    K Number
    K072035
    Device Name
    RESOLVE UVB PHOTOTHERAPY SYSTEM
    Manufacturer
    ALLUX MEDICAL
    Date Cleared
    2007-10-16

    (83 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLUX MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The Allux Medical Resolve™ UVB Phototherapy System is intended to be used with all Skin Types (I - VI).
    Device Description
    The Resolve™ UVB Phototherapy System is designed to deliver therapeutic ultraviolet-B light to a localized area onto a patient's skin surface. This system is designed to be easy to operate and is intended to be used in an outpatient setting such as a dermatologist's office under supervision of trained medical personnel. The device is comprised of two distinct components. The first is a patient attached unit and the second is a medical grade power supply. The patient attached unit is small and lightweight and is intended to be held in place or affixed to a patient at the desired treatment site. A portion of one side of the patient attached unit is composed of a fused silica transparent window out of which ultraviolet light is emitted; this window surface is intended to make contact with and lay flush to the skin thus enabling a localized treatment. The patient attached unit houses an array of ultraviolet light emitting diodes (UV-LEDs) that serve as the therapeutic light source. Additionally, the drive and control circuitry necessary to operate the UV-LEDs, as well as a fan and heat sink to dissipate waste thermal energy, are located inside the patient attached unit's protective housing. Operator interface features include on-off switch and both visual and audible status indicators.
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