Cleared Traditional

TearCare MGX System

K242786 · Sight Sciences, Inc. · Ophthalmic
Apr 2025
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K242786 is an FDA 510(k) clearance for the TearCare MGX System, a Eyelid Thermal Pulsation System (Class II — Special Controls, product code ORZ), submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 15, 2025, 211 days after receiving the submission on September 16, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K242786 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2024
Decision Date April 15, 2025
Days to Decision 211 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code ORZ — Eyelid Thermal Pulsation System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.