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U.S. Department of Health and Human Services

Product Classification
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Device electromechanical tear stimulator
Regulation Description Electromechanical tear stimulator.
Definition This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Physical State The device is a battery-operated handheld electromechanical actuator with a vibratory tip, and software controller.
Technical Method The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation mechanically activates external nasal nerve and initiates the nasolacrimal reflex, resulting in tear secretion. To produce the intended effect, the vibratory tip of the device should be applied to the lateral aspect of the nose for several seconds.
Target Area Lateral aspect of the nose.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQKV
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5305
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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