FDA applicant

Oculus Optikgerate GmbH

Wetzlar, DE8 decisions2003–20267 recalls

FDA records 8 decisions for Oculus Optikgerate GmbH (Wetzlar, DE) from 2003 to 2026: 8 510(k) clearances. Most are in product codes MXK (Device, Analysis, Anterior Segment) and HKX (Tonometer, Ac-Powered). Its devices cite 12 predicates, 6 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Oculus Optikgeräte GmbH”.

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 Oculus Optikgerate GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2023

2007high 3 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oculus Optikgerate GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oculus Optikgerate GmbH’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

Other applicant names beginning “Oculus”

FDA records each applicant name separately; these may or may not be the same firm.

Oculus Innovative Sciences 16 Oculus Private Limited 2 Oculus America 1

Oculus Optikgerate GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Oculus”