FDA 510(k)

Systane iLux2

K-Number: K200400 · 2020-05-21

Decision Date2020-05-21

Product CodeORZ

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Systane iLux2 is the device name listed in this FDA 510(k) record. The listed applicant is Tear Film Innovations, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) 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. The listed applicant is Tear Film Innovations, Inc.. The 510(k) number is K200400.

When did Systane iLux2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Systane iLux2?

The FDA 510(k) record lists Tear Film Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Systane iLux2?

The FDA product code for Systane iLux2 is ORZ.

Other records listing Tear Film Innovations, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172645iLux Instrument, iLux Disposable

Related Devices (Code: ORZ)

K252409TearCare MGX SystemSight Sciences, Inc.K242786TearCare MGX SystemSight Sciences, Inc.K240512Tixel i (TXLI0001)Novoxel , Ltd.K231084TearCare MGX SystemSight Sciences, Inc.K213045TearCare SystemSight Sciences, Inc.K192623LipiFlow Thermal Pulsation SystemTearscience, Inc.

Official Source

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