Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System

K032216 is the FDA 510(k) clearance record for BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM, a class II device, cleared for Bioptron AG on 2004-02-04 under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy). FDA's definition for product code NHN reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and...". FDA records list one 510(k) clearance for Bioptron AG. As of 2026-09-10, FDA records show no recalls naming K032216.