FDA applicant

Od-Os GmbH

Laguna Beach, CA4 decisions2009–20250 recalls

FDA records 4 decisions for Od-Os GmbH (Laguna Beach, CA) from 2009 to 2025: 4 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and GEX (Powered Laser Surgical Instrument). Its devices cite 13 predicates, 3 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 Od-Os GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

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Od-Os GmbH

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?