Cleared Traditional

iLux Instrument, iLux Disposable (K172645) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K172645 is an FDA 510(k) clearance for the iLux Instrument, iLux Disposable. Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Tear Film Innovations, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2017 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tear Film Innovations, Inc. devices

Submission Details

510(k) Number K172645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORZ Eyelid Thermal Pulsation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - ORZ Eyelid Thermal Pulsation System

All 11
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