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FDA 510(k)

Systane iLux2

K-Number: K200400 · 2020-05-21

ApplicantTear Film Innovations, Inc.
Decision Date2020-05-21
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Systane iLux2 is a medical device manufactured by Tear Film Innovations, Inc.. It received FDA 510(k) clearance on 2020-05-21 under approval number K200400. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Systane iLux2?

Systane iLux2 is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Tear Film Innovations, Inc.. The 510(k) number is K200400.

When was Systane iLux2 approved by the FDA?

Systane iLux2 received FDA 510(k) clearance on 2020-05-21, under approval number K200400.

What company makes Systane iLux2?

Systane iLux2 is manufactured by Tear Film Innovations, Inc..

What is the FDA product code for Systane iLux2?

The FDA product code for Systane iLux2 is ORZ.

Other Devices by Tear Film Innovations, Inc.

K172645iLux Instrument, iLux Disposable

Related Devices (Code: ORZ)

K161357LipiFlow Thermal Pulsation SystemTearscience, Inc. K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc. K192623LipiFlow Thermal Pulsation SystemTearscience, Inc. K213045TearCare SystemSight Sciences, Inc. K231084TearCare MGX SystemSight Sciences, Inc. K240512Tixel i (TXLI0001)Novoxel , Ltd.

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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