Cleared Traditional

TearCare MGX System

K231084 · Sight Sciences, Inc. · Ophthalmic

Dec 2023

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K231084 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 December 27, 2023, 254 days after receiving the submission on April 17, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number	K231084 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2023
Decision Date	December 27, 2023
Days to Decision	254 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.