510(k) Report

FDA applicant

Tearscience, Inc.

Morrisville, NC9 decisions2009–20192 recalls

FDA records 9 decisions for Tearscience, Inc. (Morrisville, NC) from 2009 to 2019: 8 510(k) clearances and 1 De Novo grant. Most are in product codes ORZ (Eyelid Thermal Pulsation System) and HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 14 predicates, 11 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Tearscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009: 12011: 22012: 12013: 12016: 22018: 12019: 1
2009high 2 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2017

2016: 12017: 1
2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Tearscience, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tearscience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • ORZEyelid Thermal Pulsation System5decisions
  • HKICamera, Ophthalmic, Ac-Powered4decisions

Whose devices does it build on?

Its devices cite 14 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091935Lipiview Ocular Surface InterferometerTearscience, Inc. · 20094cite it
  • DEN100017Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 20113cite it
  • K112704Lipiflow Thermal Pulsation SystemTearscience, Inc. · 20112cite it
  • K133127Lipiflow Thermal Pulsation SystemTearscience, Inc. · 20132cite it
  • K161357LipiFlow Thermal Pulsation SystemTearscience, Inc. · 20162cite it
  • K152869LipiView II Ocular Surface InterferometerTearscience, Inc. · 20161cites it

What has FDA decided for it lately?

  • K192623LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2019
  • K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc. · 2018
  • K161357LipiFlow Thermal Pulsation SystemTearscience, Inc. · 20161 recall
  • K152869LipiView II Ocular Surface InterferometerTearscience, Inc. · 2016
  • K133127Lipiflow Thermal Pulsation SystemTearscience, Inc. · 20132 recalls
  • K122481Lipiview Ocular Surface InterferometerTearscience, Inc. · 2012
  • K112704Lipiflow Thermal Pulsation SystemTearscience, Inc. · 20112 recalls
  • DEN100017Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011

All 9 as Tearscience, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K161357LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only…Jan 30, 2017Class II
  • K112704LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100…Sep 13, 2016Class II