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510(k) Data Aggregation

    K Number
    K094038
    Device Name
    COMPACT TOUCH
    Manufacturer
    QUANTEL S.A.
    Date Cleared
    2010-04-22

    (113 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTEL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: - Visualization of the interior of the eye and the orbit by A and B scans. - Axial Length measurement of the eye by ultrasonic means. - Implanted IOL power calculation, using the Axial Length measurement. - Measurement of corneal thickness by ultrasonic means.
    Device Description
    The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe.
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    K Number
    K081095
    Device Name
    PROLITE III TOWER AND PR AND HR HANDPIECE
    Manufacturer
    QUANTEL S.A.
    Date Cleared
    2008-12-12

    (239 days)

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

    QUANTEL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750 - 1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types. The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.
    Device Description
    The ProLite III IPL is a device designed for dermatological use. It produces an intense light pulse within the wavelengths of 450 to 2000 nanometers, which is tailored to specific indications by a bandpass filter. The system is composed of a Tower which encloses the power supply and cooling system and a Handpiece which contains the flash lamp, filter and waveguide. The device is controlled by a touchscreen graphic user interface.
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