BIOPTRON AG - Assuring top quality
BIOPTRON AG in-house laboratories are constantly engaged in testing. BIOPTRON devices are evaluated scientific studies carried out by independent institutions. Simultaneously, BIOPTRON devices are further certified by accredited independent testing institutes. Our business processes, including R&D, supplier evaluation, supply of components to production, on going inspections and the product itself, fulfil all regulations pursuant to the European Community medical directive 93/427EEC, as well as particular national regulations of the local markets.
1. DEKRA ISO Certificate for Quality Management System EN ISO 9001:2008.
2. DEKRA ISO Certificate for Quality Management System EN ISO 13485:2012 + AC:2012.
3. DEKRA ISO Certificate for Quality Management System ISO 13485-2003- CMDCAS.
4. DEKRA CE Certificate for the Quality Assurance System, Medical Device directive 93/42/EEC, annex II excluding section (4).
5. 510(K) Clearance, for further information visit "510(k) Premarket Notification Database" http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
Our 510(k) No: K032216.
- DEKRA ISO certificate for Quality Management System: ISO 9001:2008 and EN ISO 13485:2012 + AC:2012, issued in 19.07.2016 and ISO 13485-2003- CMDCAS, certified since 24.09.2013.
- DEKRA EC certificate for the Quality Assurance System according to the Medical Device directive 93/42/EEC, annex II excluding section (4), issued in 19.07.2016.
- DEKRA is an accredited notified body with ID 0124.
Science and research
Years of experience and research have affirmed the positive effects of BIOPTRON Light Therapy and have led to a wide range of applications in numerous fields of medicine. The scientific team of BIOPTRON AG is working continuously with experts, researchers and physicians in many countries in order to examine the characteristics and therapeutic effectiveness of BIOPTRON Light Therapy.
Scientific references list
Doctors around the world recommend the use of the BIOPTRON Light Therapy.
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 M.Fenyö, J.Mandl and A.Falus: Opposite effect of linearly polarized light on biosynthesis of interleukin-6 in a human B lymphoid cell line and peripheral human monocytes. Cell Biology International, 2002, 26(3); 265-269.
 T.Kubasova, M.Fenyö, Z.Somosy, L.Gazso and I.Kertesz: Investigations on biological effect of polarized light. Photochemistry and Photobiology, 1988, 48; 505-509.
 P.Bolton, M.Dyson and S.Young: The effect of polarized light on the release of growth factors from the U-937 macrophage-like cell line. Laser Therapy, 1992, 2(3); 33-37.
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 K.A.Samoilova, K.D.Obolenskaya, A.V.Vologdina, S.A.Snopov and E.V.Shevchenko: Single skin exposure to visible light induces rapid modification of entire circulation blood - 1. Improvement of rheologic and immune parameters. Progress in Biomedical Optics/Proceedings of Low-Power Light on Biological Systems, 1998, IV; 90-103.
 J.E.Roberts: Visible light induces changes in the immune response through an eye-brain mechanism (photoneuroimmunology), Journal of Photochemistry and Photobiology, B: Biology, 1995, 29(1); 3-15.
 L.Medenica and M.Lens: The use of polarised polychromatic non-coherent light alone as a therapy for venous leg ulceration. Journal of Wound Care, 2003, 12(1); 37-40.
 S.Monstrey, H.Hoeksema, H.Saelens, K.Depuydt, M.Hamdi, K.Van Landuyt and P.Blondeel: A conservative approach for deep dermal burn wounds using polarised-light therapy. British Journal of Plastic Surgery, 2002, 55; 420-426.
 10. P.Iordanou, G.Baltopoulos, M.Giannakopoulou, P.Bellou and E.Ktenas: Effect of polarized light in the healing process of pressure ulcers. International Journal of Nursing Practice, 2002, 8(1); 49-55.
 S.Monstrey, H.Hoeksema, K.Depuydt, G.Van Maele, K.Van Landuyt and P.Blondeel: The effect of polarized light on wound healing. European Journal of Plastic Surgery, 2002, 24(8); 377-382.
Invited commentary: W.Vanscheidt, The effect of polarized light on wound healing. European Journal of Plastic Surgery, 2002, 24(8); 383.
 Colic MM, Vidojkovic N, Jovanovic M, Lazovic G. The use of polarized light in aesthetic surgery. Aesthetic Plast.Surg. 2004;28(5):324-7.
 Tomashuk IP, Tomashuk II. [Clinical efficacy of alprostan in combination with "Bioptron-II" rays and iruxol-miramistin in the treatment of the diabetic foot complicated by atherosclerosis]. Klin.Khir. 2001;(8):49-51.
 M.F.Ballyzek, V.Vesovic-Potic, X.He, A.Johnston: Efficacy of polarized, polychromatic, non-coherent light in the treatment of chronic musculoskeletal neck and shoulder pain. Unpublished material, BIOPTRON AG, Wollerau, Switzerland (2005).
 Stasinopoulos D. The use of polarized polychromatic non-coherent light as therapy for acute tennis elbow/lateral epicondylalgia: a pilot study. Photomedicine and Laser Surgery 2005;23(1):66-69.
 D.Stasinopoulos, I.Stasinopoulos and M.I.Johnson: Treatment of carpal tunnel syndrome with polarized polychromatic noncoherent light (Bioptron light): a preliminary, prospective, open clinical trial. Photomedicine and Laser Surgery, 2005;23(2):225-228.
 I.Stasinopoulos: Report of the rheumatology and rehabilitation centre. Unpublished material, Greece (1990).
 Lymans'kyi I, Tamarova ZA, Huliar SO. [Suppression of visceral pain by action of the low intensity polarized light on acupuncture antinociceptive points]. Fiziol.Zh. 2003;49(5):43-51.
 Aronis, A.Braziotis, K.Kafouros, N.Pagratis, Th.Papakostas and P.Venetsanos: The action of visible polarized light on skin diseases. Poster presentation at the 18th International Congress of Dermatology, New York, USA (1992).
 Bartos Z.; The use of the BIOPTRON Light Therapy System in the treatment of skin disorders; Kiskunfélegyháza City Hospital and Polyclinic Department of Dermatological and Venerreal Diseases; Experience report; Hungary (2004).
 Charakida Aikaterini, Deaton Edward D. Charakida Marietta, Mouser Paul et al.; Phototherapy in the Treatment of Acne Vulgaris. What is the Role?; Am J Clin Dermatol; 5(4):211-216(2004).
 Burkin IA, Okateyev VS, 2004. The use of BIOPTRON Light Therapy in the treatment of children with musculoskeletal injuries. Clinical Experience Report. Traumatology Department, Sperandsky; Municipal Children's Hospital, Moscow, Russia.
 Cerná O. The BIOPTRON Light Therapy in the life support and intensive care unit, Abstract, Congress Proceedings, Prague, Czechoslovakia 2005.
 Khan MA, 2001, Report on use of BIOPTRON polychromatic incoherent polarized light in paediatrics, Experience Report. Russian Scientific Centre of Reconstructive Medicine and Balneotherapy, Moscow, Russia.
 Khan MA, Erdes SI. Clinical efficiency of BIOPTRON polychromatic polarized light in the treatment of atopic dermatitis and frequent respiratory diseases in children, Allergology and Immunology in Paediatrics, N3 (14), September 2008.
 Avery DA, Kizer D, Bolte MA et al.: Bright light therapy of subsydromal seasonal affective disorders in the workplace: morning vs. afternoon exposure. Acta Psychiatrica Scandinavica 2001; 103:267 -274.
 Eastrnan Cl, Young MA, Fogg LF, Lìu L, Meaden PM: Bright light treatment of winter depression: a placebo-controlled trial. Arch Gen Psychiatry 1998; 55: BB3 - 889.
 Lam RW and Levitt A: Canadian Consensus Guidelines for the Treatment of SAD, A Summary of the Report of the Canadian Consensus Group on SAD, Can J Diagnosis 1998; Suppl. 1 - l5.
 Lee TM, Chan CC: Dose-response relationship of phototherapy for seasonal affective disorder: a meta'analysis. Acta Psychiatr Scand 1999; 99; 315 – 323.