FDA applicant

Lasertek OY

Mchenry, IL4 decisions1979–19840 recalls

FDA records 4 decisions for Lasertek OY (Mchenry, IL) from 1979 to 1984: 4 510(k) clearances. All are in product code HQF (Laser, Ophthalmic). 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 Lasertek OY’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lasertek OY since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Lasertek OY

Which product codes does it file in?

What has FDA decided for it lately?