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FDA 510(k)

iLux Instrument, iLux Disposable

K-Number: K172645 · 2017-12-26

ApplicantTear Film Innovations, Inc.
Decision Date2017-12-26
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iLux Instrument, iLux Disposable 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 2017-12-26 under 510(k) number K172645. 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 iLux Instrument, iLux Disposable?

iLux Instrument, iLux Disposable is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Tear Film Innovations, Inc.. The 510(k) number is K172645.

When did iLux Instrument, iLux Disposable receive FDA 510(k) clearance?

iLux Instrument, iLux Disposable received FDA 510(k) clearance on 2017-12-26, under 510(k) number K172645.

Who is the listed applicant for iLux Instrument, iLux Disposable?

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 iLux Instrument, iLux Disposable?

The FDA product code for iLux Instrument, iLux Disposable 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.

K200400Systane iLux2

Related Devices (Code: ORZ)

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.

K252409TearCare MGX SystemSight Sciences, Inc.K242786TearCare MGX SystemSight Sciences, Inc.K240512Tixel i (TXLI0001)Novoxel , Ltd.K231084TearCare MGX SystemSight Sciences, Inc.K213045TearCare SystemSight Sciences, Inc.K200400Systane iLux2Tear Film Innovations, Inc.

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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