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510(k) Data Aggregation
K Number
DEN190026Device Name
iTEAR Neurostimulator
Manufacturer
Date Cleared
2020-05-01
(352 days)
Regulation Number
886.5305Why did this record match?
Applicant Name (Manufacturer) :
Olympic Ophthalmics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
Device Description
iTEAR100 Neurostimulator is a hand-held, portable electromechanical actuator intended to acutely increase tear production through vibratory stimulation of the external nasal nerve in patients. The device is battery-operated with a single vibratory tip. As the effective tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device. The device is comprised of a direct current vibration motor, vibrating beam(cantilever), a control circuit with micro SD card, tactile switch.
The motor is attached to a cantilever beam made from acrylonitrile butadiene styrene (ABS), a control circuit to charge the battery and deliver power to the motor, and a housing also made from ABS. The motor and cantilever beam move together to produce a linear vibration at the tip of the cantilever (oscillating tip). A lithium-ion rechargeable battery is supplied inside the device, and is not removable or replaceable. A micro USB port on the device allows for charging. The device is locked by firmware from use after a predetermined number of stimulation days has been triggered.
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