510(k) Report

FDA applicant

Lokki Lasers Medicaux

Centercille, MA1 decision2003–20030 recalls

FDA records 1 decision for Lokki Lasers Medicaux (Centercille, MA) in 2003: 1 510(k) clearance. All are in product code 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, dental panel, where it files most

How often FDA has decided Lokki Lasers Medicaux’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lokki Lasers Medicaux since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • EBZActivator, Ultraviolet, For Polymerization1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K024374Rmo Plasma Curing LightLokki Lasers Medicaux · 20031cites it

What has FDA decided for it lately?

  • K024374Rmo Plasma Curing LightLokki Lasers Medicaux · 2003

The one decision as Lokki Lasers Medicaux →

Other applicant names beginning “Lokki”

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

Lokki 2