LipiFlow Thermal Pulsation System— 510(k) K161357

Substantially Equivalent

Tearscience, Inc.

FDA 510(k) clearance K161357 for LipiFlow Thermal Pulsation System, Substantially Equivalent on 2016-11-04. Applicant: Tearscience, Inc..

Clearance details

Applicant: Tearscience, Inc.
Product code: Code ORZ
Advisory panel: Ophthalmic
Date received: 2016-05-16
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

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