LipiFlow Thermal Pulsation System— 510(k) K161357

Name: FDA 510(k) clearance K161357
Creator: U.S. Food and Drug Administration
Published: 2016-11-04

Substantially Equivalent

Tearscience, Inc.

FDA 510(k) clearance K161357 for LipiFlow Thermal Pulsation System, Substantially Equivalent on 2016-11-04. Applicant: Tearscience, Inc.. Device class: 2.

Clearance details

Applicant: Tearscience, Inc.
Product code: Code ORZ
Device class: Class 2
Regulation: 21 CFR 886.5200
Advisory panel: Ophthalmic
Date received: 2016-05-16
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ORZ

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K152869 — LipiView II Ocular Surface Interferometer2016-01-14
K133127 — LIPIFLOW THERMAL PULSATION SYSTEM2013-12-23
K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETER2012-12-31

Recalls naming K161357

K-number listed on FDA's recall record

Z-1535-2017 — LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, SterileClass II·Terminated·Tearscience, Inc·20170130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161357.

Data sourced from openFDA. This site is unofficial and independent of the FDA.