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 a medical device manufactured by Tear Film Innovations, Inc.. It received FDA 510(k) clearance on 2017-12-26 under approval 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. It is manufactured by Tear Film Innovations, Inc.. The 510(k) number is K172645.
When was iLux Instrument, iLux Disposable approved by the FDA?
iLux Instrument, iLux Disposable received FDA 510(k) clearance on 2017-12-26, under approval number K172645.
What company makes iLux Instrument, iLux Disposable?
iLux Instrument, iLux Disposable is manufactured by Tear Film Innovations, Inc..
What is the FDA product code for iLux Instrument, iLux Disposable?
The FDA product code for iLux Instrument, iLux Disposable is ORZ.
Other Devices by Tear Film Innovations, Inc.
Related Devices (Code: ORZ)
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.