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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name electromechanical tear stimulator
De Novo Number DEN190026
Device Name iTEAR Neurostimulator
Requester
olympic ophthalmics, inc.
400 nw gilman blvd. #1370
issaquah,  WA  98027
Contact michael gertner
Regulation Number886.5305
Classification Product Code
QKV  
Date Received05/15/2019
Decision Date 05/01/2020
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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