510(k) Report

FDA applicant

Laser Industries, Ltd.

Mchenry, IL20 decisions1978–19940 recalls

FDA records 20 decisions for Laser Industries, Ltd. (Mchenry, IL) from 1978 to 1994: 20 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FDC (Resectoscope, Working Element). 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, general and plastic surgery panel, where it files most

How often FDA has decided Laser Industries, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Laser Industries, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Laser”

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