510(k) Report

FDA applicant

Bioptron AG

Littleton, CO1 decision2004–20040 recalls

FDA records 1 decision for Bioptron AG (Littleton, CO) in 2004: 1 510(k) clearance. All are in product code NHN (Powered Light Based Laser Non-Thermal…). 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, physical medicine panel, where it files most

How often FDA has decided Bioptron AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioptron AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioptron AG 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?

  • NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive…1decision

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.

  • K032216Bioptron Pro Light Therapy System and Bioptron Compact Iii Light Therapy SystemBioptron AG · 20041cites it

What has FDA decided for it lately?

  • K032216Bioptron Pro Light Therapy System and Bioptron Compact Iii Light Therapy SystemBioptron AG · 2004

The one decision as Bioptron AG →