Cleared Special

K262479 - TearCare System

K262479 is an FDA 510(k) clearance for TearCare System, manufactured by Sight Sciences, Inc.. The device is a Class 2 Ophthalmic device with product code ORZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K262479 · Sight Sciences, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
29d
Days
Class 2
Risk

K262479 is an FDA 510(k) clearance for the TearCare 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 August 18, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262479

510(k) Number K262479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2026
Decision Date August 18, 2026
Days to Decision 29 days
Submission Type Special
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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K262479.
TearCare MGX System
K252409 · Sight Sciences, Inc. · Apr 2026
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
K262479 · TearCare System
Download PDF FDA Summary Sight Sciences, Inc.