Cleared Traditional

TearCare System

K213045 · Sight Sciences, Inc. · Ophthalmic
Dec 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K213045 is an FDA 510(k) clearance for the TearCare 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 21, 2021, 90 days after receiving the submission on September 22, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K213045 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2021
Decision Date December 21, 2021
Days to Decision 90 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.