Cleared Special

K161357 - LipiFlow Thermal Pulsation System

K161357 is an FDA 510(k) clearance for LipiFlow Thermal Pulsation System, manufactured by Tearscience, Inc.. The device is a Class 2 Ophthalmic device with product code ORZ cleared through the Special 510(k) pathway after a 172-day FDA review.

K161357 · Tearscience, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
172d
Days
Class 2
Risk

K161357 is an FDA 510(k) clearance for the LipiFlow Thermal Pulsation System. Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Tearscience, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 172 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161357

510(k) Number K161357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 110d · This submission: 172d
Pathway characteristics
Modification to existing cleared device.

ORZ Device Classification - Class 2, Special Controls

Product Code ORZ Eyelid Thermal Pulsation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - ORZ Eyelid Thermal Pulsation System

All 12
Devices cleared under the same product code (ORZ) and FDA review panel - the closest regulatory comparables to K161357.
Systane iLux2
K200400 · Tear Film Innovations, Inc. · May 2020
LipiFlow Thermal Pulsation System
K192623 · Tearscience, Inc. · Oct 2019
iLux Instrument, iLux Disposable
K172645 · Tear Film Innovations, Inc. · Dec 2017
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · Tearscience, Inc. · Dec 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K112704 · Tearscience, Inc. · Dec 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · Tearscience, Inc. · Jun 2011
K161357 · LipiFlow Thermal Pulsation System
Download PDF FDA Summary Tearscience, Inc.