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
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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.

View all Tearscience, Inc. devices

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