ITEAR Neurostimulator

Electromechanical Tear Stimulator

Olympic Ophthalmics, Inc.

The following data is part of a De Novo classification by Olympic Ophthalmics, Inc. with the FDA for Itear Neurostimulator.

Pre-market Notification Details

DeNovo IDDEN190026
Device Name:ITEAR Neurostimulator
ClassificationElectromechanical Tear Stimulator
Applicant Olympic Ophthalmics, Inc. 400 Nw Gilman Blvd. #1370 Issaquah,  WA  98027
ContactMichael Gertner
Product CodeQKV  
CFR Regulation Number886.5305 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOphthalmic
Classification AdvisoryOphthalmic
TypeDirect
Date Received2019-05-15
Decision Date2020-05-01
Reclassification Order:Reclassification Order

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