iLux Instrument, iLux Disposable— 510(k) K172645

Name: FDA 510(k) clearance K172645
Creator: U.S. Food and Drug Administration
Published: 2017-12-26

Substantially Equivalent

Tear Film Innovations, Inc.

FDA 510(k) clearance K172645 for iLux Instrument, iLux Disposable, Substantially Equivalent on 2017-12-26. Applicant: Tear Film Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Tear Film Innovations, Inc.
Product code: Code ORZ
Device class: Class 2
Regulation: 21 CFR 886.5200
Advisory panel: Ophthalmic
Date received: 2017-09-01
Decision date: 2017-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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