FDA applicant

Optomed OY

Oulu, FI7 decisions1993–20180 recalls

FDA records 7 decisions for Optomed OY (Oulu, FI) from 1993 to 2018: 7 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and GEX (Powered Laser Surgical Instrument). Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Optomed Corp.”.

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 Optomed OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optomed OY’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 “Optomed”

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

Optomed Oyj 1

Optomed OY

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?

Other applicant names beginning “Optomed”