Cleared Traditional

LIPIFLOW THERMAL PULSATION SYSTEM (K133127) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133127 · Tearscience, Inc. · Ophthalmic device
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Dec 2013
Decision
84d
Days
Class 2
Risk

K133127 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 23, 2013 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tearscience, Inc. devices

Submission Details

510(k) Number K133127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date December 23, 2013
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 11
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