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U.S. Department of Health and Human Services

Product Classification

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Device intranasal electrostimulation device
Regulation Description Tear electrostimulation device.
Definition This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Physical State The intranasal tear neurostimulator is a handheld device with two electroconductive tips that are inserted into the nasal cavity during neurostimulation. The disposable tips are made of rigid biocompatible USP Class VI plastic and the conductive tips are made of silicone hydrogel. Additional hardware components include a reusable base, charging station, and cover. The base has two buttons that allow the user to select the stimulation level (device is locked from use after a predetermined amount of stimulation has been triggered).The device is powered by a rechargeable battery. Once the tips are removed, the base can be inverted and placed in the charger to replenish the battery.
Technical Method The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation activates the primary sensory afferent fibers in the ophthalmic and maxillary branches of the trigeminal nerve (CNV1 and CNV2). The device design limits the insertion length of the intranasal tips to ensure the probes do not physically reach the olfactory nerve fibers of nasal mucosa. The pulses delivered by the Intranasal Tear Neurostimulator induce action potentials in the surrounding nerve tissue by creating transient voltage depolarization in activated neurons. This neural activation initiates the nasolacrimal reflex, resulting in tear secretion.
Target Area Nose.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePQJ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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