510(k) Report

FDA applicant

Tear Film Innovations, Inc.

Carlsbad, CA2 decisions2017–20200 recalls

FDA records 2 decisions for Tear Film Innovations, Inc. (Carlsbad, CA) from 2017 to 2020: 2 510(k) clearances. All are in product code ORZ (Eyelid Thermal Pulsation System). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is 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 Tear Film Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Tear Film Innovations, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • ORZEyelid Thermal Pulsation System2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc. · 20172cite it

What has FDA decided for it lately?

  • K200400Systane iLux2Tear Film Innovations, Inc. · 2020
  • K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc. · 2017

All 2 as Tear Film Innovations, Inc. →