Not Cleared Post-NSE

LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (DEN100017) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN100017 · Tearscience, Inc. · Ophthalmic device
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Jun 2011
Decision
323d
Days
Class 2
Risk

DEN100017 is an FDA 510(k) submission (not cleared) for the LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM). Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Tearscience, Inc. (Morrisville, US). The FDA issued a Not Cleared (DENG) decision on June 28, 2011 after a review of 323 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 323 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Tearscience, Inc. devices

Submission Details

510(k) Number DEN100017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2010
Decision Date June 28, 2011
Days to Decision 323 days
Submission Type Post-NSE
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 110d · This submission: 323d
Pathway characteristics

Device Classification

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

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