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 a medical device manufactured by Olympic Ophthalmics. It received FDA 510(k) clearance on 2022-03-16 under approval 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. It is manufactured by Olympic Ophthalmics. The 510(k) number is K213623.
When was iTEAR100 Neurostimulator approved by the FDA?
iTEAR100 Neurostimulator received FDA 510(k) clearance on 2022-03-16, under approval number K213623.
What company makes iTEAR100 Neurostimulator?
iTEAR100 Neurostimulator is manufactured by Olympic Ophthalmics.
What is the FDA product code for iTEAR100 Neurostimulator?
The FDA product code for iTEAR100 Neurostimulator is QKV.
Related Devices (Code: 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.