K-number	K213623
Device name	iTEAR100 Neurostimulator
Applicant	Olympic Ophthalmics
Product code	QKV
Device class	Class II
Decision date	Mar 16, 2022
Decision	Substantially Equivalent
Regulation	886.5305

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Source

View the full FDA submission: accessdata.fda.gov

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iTEAR100 Neurostimulator

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