Cleared Traditional

iLux Instrument, iLux Disposable

K172645 · Tear Film Innovations, Inc. · Ophthalmic
Dec 2017
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K172645 is an FDA 510(k) clearance for the iLux Instrument, iLux Disposable, a Eyelid Thermal Pulsation System (Class II — Special Controls, product code ORZ), submitted by Tear Film Innovations, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2017, 116 days after receiving the submission on September 1, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K172645 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2017
Decision Date December 26, 2017
Days to Decision 116 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code ORZ — Eyelid Thermal Pulsation System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.