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510(k) Data Aggregation

    K Number
    K052336
    Device Name
    SPECTRAQUATTRO PULSED LIGHT SYSTEM
    Date Cleared
    2005-10-11

    (46 days)

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

    AMJET DISTRIBUTION, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SpectraQuattro™ Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro™ Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris. SpectraQuattro™ comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended: | Light Spectrum Filter | Indications | |-----------------------|--------------------------------------------------------------------------| | 410-1200 | Mild to moderate inflammatory and pustular inflammatory acne<br>vulgaris | | 530-1200 | pigmented lesions | | 560-1200 | lentigenes | | 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins | | 640-1200 | Hair removal |
    Device Description
    The SpectraQuattro Pulsed Light System is intended to provide phototherapeutic light to the body. The SpectraQuattro is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console which houses the power supply, cooling system, handpiece that contains the light source, and footswitch.
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