Cleared Traditional

K200400 - Systane iLux2

K200400 is the FDA 510(k) clearance for Systane iLux2 by Tear Film Innovations, Inc.. It is a Class 2 Ophthalmic device (product code ORZ) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K200400 · Tear Film Innovations, Inc. · Ophthalmic device
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May 2020
Decision
93d
Days
Class 2
Risk

K200400 is an FDA 510(k) clearance for the Systane iLux2. Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Tear Film Innovations, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2020 after a review of 93 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 K200400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date May 21, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
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.