BIOPTRON AG in-house laboratories are constantly engaged in the testing and optimization of BIOPTRON devices in line with the latest scientific studies carried out by independent institutions. Simultaneously, BIOPTRON devices are further certified by accredited, independent testing institutions. Our business processes, including R&D, supplier evaluation, the supply of components to production, ongoing inspections and the production of all devices, comply with the European Community medical directive 93/427EEC as well as with specific local market regulations.
510 (k) clearance for pain
For further information visit "510(k) Premarket Notification Database" Our 510(k) No: K032216