K-number	DEN190026
Device name	iTEAR Neurostimulator
Applicant	Olympic Ophthalmics, Inc.
Product code	QKV
Device class	Class II
Decision date	May 1, 2020
Decision	Not Substantially Equivalent
Regulation	886.5305

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Source

View the full FDA submission: accessdata.fda.gov

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iTEAR Neurostimulator

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