Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K230905
    Device Name
    OrthoPulse 2.0E (OPi2E-100)
    Date Cleared
    2023-06-09

    (70 days)

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

    Biolux Technology GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoPulse® device is intended to accelerate orthodontic movement of teeth which may reduce the overall treatment time for the patient. The OrthoPulse® device is intended for use during orthodontic treatment. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
    Device Description
    OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. The OrthoPulse device is an intra-oral appliance 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/cm² for the patient. The device is designed to comply with applicable medical device standards. OrthoPulse includes light with wavelengths in the 850 nm 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 (firmware). OrthoPulse includes an integrated battery for power. The battery is rechargeable via a wireless charging platform / storage case. OrthoPulse contains a Bluetooth LE transmitter module that operates at 2.4 GHz. This module is active only when the device is not in use, but placed in the charging case and the 'Ready for Bluetooth' indicator is on.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1