Product code QKV

Device name: Electromechanical Tear Stimulator
Medical specialty: Ophthalmic
Device class: 2
Regulation number: 886.5305
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K213623	iTEAR100 Neurostimulator	Olympic Ophthalmics	2022-03-16
DEN190026	iTEAR Neurostimulator	Olympic Ophthalmics, Inc.	2020-05-01

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