Cleared Traditional

K200400 - Systane iLux2

K200400 is an FDA 510(k) clearance for Systane iLux2, manufactured by Tear Film Innovations, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K200400

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.

ORZ Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (ORZ) and FDA review panel - the closest regulatory comparables to K200400.
Tixel i (TXLI0001)
K240512 · Novoxel , Ltd. · Nov 2024
TearCare MGX System
K231084 · Sight Sciences, Inc. · Dec 2023
TearCare System
K213045 · Sight Sciences, Inc. · Dec 2021
LipiFlow Thermal Pulsation System
K192623 · Tearscience, Inc. · Oct 2019
iLux Instrument, iLux Disposable
K172645 · Tear Film Innovations, Inc. · Dec 2017
LipiFlow Thermal Pulsation System
K161357 · Tearscience, Inc. · Nov 2016