510(k) Report

FDA applicant

Ion Laser Technology

Salt Lake City, UT9 decisions1991–19980 recalls

FDA records 9 decisions for Ion Laser Technology (Salt Lake City, UT) from 1991 to 1998: 9 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and EBZ (Activator, Ultraviolet, For Polymerization). 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 Ion Laser Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ion Laser Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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