Cleared Traditional

K112704 - LIPIFLOW THERMAL PULSATION SYSTEM

K112704 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 Traditional 510(k) pathway after a 94-day FDA review.

K112704 · Tearscience, Inc. · Ophthalmic device
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Dec 2011
Decision
94d
Days
Class 2
Risk

K112704 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 December 19, 2011 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tearscience, Inc. devices

FDA 510(k) Submission Details - K112704

510(k) Number K112704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2011
Decision Date December 19, 2011
Days to Decision 94 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 110d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K112704.
iLux Instrument, iLux Disposable
K172645 · Tear Film Innovations, Inc. · Dec 2017
LipiFlow Thermal Pulsation System
K161357 · Tearscience, Inc. · Nov 2016
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · Tearscience, Inc. · Dec 2013
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · Tearscience, Inc. · Jun 2011