LipiFlow Thermal Pulsation System

Eyelid Thermal Pulsation System

TEARSCIENCE, INC.

The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiflow Thermal Pulsation System.

Pre-market Notification Details

Device IDK161357
510k NumberK161357
Device Name:LipiFlow Thermal Pulsation System
ClassificationEyelid Thermal Pulsation System
Applicant TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville,  NC  27560
ContactChristy Coleman
CorrespondentChristy Coleman
TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville,  NC  27560
Product CodeORZ  
CFR Regulation Number886.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-16
Decision Date2016-11-04
Summary:summary

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