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510(k) Data Aggregation

    K Number
    K143120
    Device Name
    OrthoPulse
    Date Cleared
    2015-07-24

    (267 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLUX RESEARCH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoPulse™ device is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
    Device Description
    The OrthoPulse'''' device is an intra-oral appliance similar to a plastic sports mouth guard that is intended for use during orthodontic treatment in conjunction with traditional orthodontic treatment with brackets and wires or aligners. The device achieves its effect by delivering light energy to the bone, accelerating the rate of tooth movement. Light-emitting diodes ("LEDs") are embedded into the mouth-guard on a flexible circuit. Light is directed toward the alveolar surface to facilitate light treatment of the anterior arch segment during orthodontic tooth movement. The intra-oral appliance is designed to treat one arch (upper or lower), and is reversible by the patient to treat the other arch. OrthoPulse is considered a low level light treatment device and produces light at levels 50-80 mW/cm for the patient. The device is designed to comply with the lamp safety standard (IEC 62471: 2006) and with the general medical device standard IEC 60601-1 3rd Ed. OrthoPulse includes light with wavelengths in the 850nm range (near infrared) and the treatment protocol is based on a daily treatment session of 5 minutes per arch (maxilla or mandible). The treatment time (session duration) is controlled by the software, along with the number of treatments per day. OrthoPulse includes an integrated battery for power. The battery is rechargeable via a wireless charging platform / storage case. The device provides a wireless connection to an optional iOS application to enable monitoring of patient compliance with the treatment regimen. No other cable or connection to external devices is required.
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