Cleared Special

LipiFlow Thermal Pulsation System

K192623 · Tearscience, Inc. · Ophthalmic
Oct 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K192623 is an FDA 510(k) clearance for the LipiFlow Thermal Pulsation System, a Eyelid Thermal Pulsation System (Class II — Special Controls, product code ORZ), submitted by Tearscience, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 22, 2019, 29 days after receiving the submission on September 23, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K192623 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2019
Decision Date October 22, 2019
Days to Decision 29 days
Submission Type Special
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.