510(k) Report

FDA applicant

Leo Unlimited, Inc.

Mchenry, IL3 decisions1983–19840 recalls

FDA records 3 decisions for Leo Unlimited, Inc. (Mchenry, IL) from 1983 to 1984: 3 510(k) clearances. Most are in product codes KCW (Epilator, High Frequency, Needle-Type) and IPF (Stimulator, Muscle, Powered). 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 Leo Unlimited, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leo Unlimited, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leo Unlimited, Inc. 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?

  • KCWEpilator, High Frequency, Needle-Type2decisions
  • IPFStimulator, Muscle, Powered1decision

What has FDA decided for it lately?

  • K834572Epitron SuperLeo Unlimited, Inc. · 1984
  • K833946Epilot 80 S TMLeo Unlimited, Inc. · 1984
  • K833945Cosmodyn-S Interferential Muscle StimLeo Unlimited, Inc. · 1983

All 3 as Leo Unlimited, Inc. →