Cleared Traditional

TearCare MGX System (K252409) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K252409 · Sight Sciences, Inc. · Ophthalmic device
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Apr 2026
Decision
269d
Days
Class 2
Risk

K252409 is an FDA 510(k) clearance for the TearCare MGX System. Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 27, 2026 after a review of 269 days - an extended review cycle.

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 Sight Sciences, Inc. devices

Submission Details

510(k) Number K252409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date April 27, 2026
Days to Decision 269 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
159d slower than avg
Panel avg: 110d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04795752 Completed Interventional Industry-sponsored

Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

345
Patients (actual)
14
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Dry Eye; Meibomian Gland Dysfunction
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Jaime Dickerson, PhD
Sponsor Sight Sciences, Inc. (industry)
Started 2021-04-28 → Primary completion 2024-09-23
Primary outcome
Tear Break-Up Time
View full study on ClinicalTrials.gov

Regulatory Peers - ORZ Eyelid Thermal Pulsation System

All 11
Devices cleared under the same product code (ORZ) and FDA review panel - the closest regulatory comparables to K252409.
TearCare MGX System
K242786 · Sight Sciences, Inc. · Apr 2025
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
Systane iLux2
K200400 · Tear Film Innovations, Inc. · May 2020
LipiFlow Thermal Pulsation System
K192623 · Tearscience, Inc. · Oct 2019