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FDA 510(k)

iTEAR100 Neurostimulator

K-Number: K213623 · 2022-03-16

ApplicantOlympic Ophthalmics
Decision Date2022-03-16
Product CodeQKV
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iTEAR100 Neurostimulator is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Ophthalmics. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K213623. The device is classified under product code QKV. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTEAR100 Neurostimulator?

iTEAR100 Neurostimulator is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Olympic Ophthalmics. The 510(k) number is K213623.

When did iTEAR100 Neurostimulator receive FDA 510(k) clearance?

iTEAR100 Neurostimulator received FDA 510(k) clearance on 2022-03-16, under 510(k) number K213623.

Who is the listed applicant for iTEAR100 Neurostimulator?

The FDA 510(k) record lists Olympic Ophthalmics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTEAR100 Neurostimulator?

The FDA product code for iTEAR100 Neurostimulator is QKV.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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