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510(k) Data Aggregation
K Number
K230905Device Name
OrthoPulse 2.0E (OPi2E-100)
Manufacturer
Date Cleared
2023-06-09
(70 days)
Product Code
Regulation Number
872.5470Why did this record match?
Product Code :
PLH
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.
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K Number
K143120Device Name
OrthoPulse
Manufacturer
Date Cleared
2015-07-24
(267 days)
Product Code
Regulation Number
872.5470Why did this record match?
Product Code :
PLH
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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