Cleared Special

LipiFlow Thermal Pulsation System

K161357 · Tearscience, Inc. · Ophthalmic
Nov 2016
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K161357 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. (Morrisville, US). The FDA issued a Cleared decision on November 4, 2016, 172 days after receiving the submission on May 16, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K161357 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2016
Decision Date November 04, 2016
Days to Decision 172 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.