LipiFlow Thermal Pulsation System— 510(k) K192623

Name: FDA 510(k) clearance K192623
Creator: U.S. Food and Drug Administration
Published: 2019-10-22

Substantially Equivalent

Tearscience, Inc.

FDA 510(k) clearance K192623 for LipiFlow Thermal Pulsation System, Substantially Equivalent on 2019-10-22. Applicant: Tearscience, Inc.. Device class: 2.

Clearance details

Applicant: Tearscience, Inc.
Product code: Code ORZ
Device class: Class 2
Regulation: 21 CFR 886.5200
Advisory panel: Ophthalmic
Date received: 2019-09-23
Decision date: 2019-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ORZ

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More clearances from Tearscience, Inc.

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K182506 — LipiScan Dynamic Meibomian Imager2018-12-10
K161357 — LipiFlow Thermal Pulsation System2016-11-04
K152869 — LipiView II Ocular Surface Interferometer2016-01-14
K133127 — LIPIFLOW THERMAL PULSATION SYSTEM2013-12-23
K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETER2012-12-31

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