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      Quality Certifications

      CONFIDENCE THROUGH EFFICACY, QUALITY & CERTIFICATION.

      Lexington International LLC. is dedicated to providing products that consistently meet or exceed the requirements and expectations of our customers. The application of a rigorous Quality Management System, including a commitment to comply with regulatory requirements ensures the highest possible environmental and safety standards.

      • Final laser diode validation and inspection

      • Automated laser diode fabrication

      • Pallet of LaserBand 82

      • LaserBand 82 laser diodes

      All manufacturing processes are state-of-the-art and ISO Quality Assured.

      • ISO 13485:2003 – Quality System Certification
      • ISO 9001:2008 – Quality System Certification
      • IEC60825-1:2007 – 03 ED2.0
      • USFDA Good Manufacturing Practices (GMP) – We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations

      Europe * Emergo Europe, The Hague, Netherlands. Telephone: 31.70.345.8570 http://www.EmergoGroup.com

      Registrar The HairMax LaserComb devices maintain ISO 13485:2003 and 9001:2008 certifications and are audited by: InterTek Testing Services 70 Codman Hill Road Boxbourough, MA 01719 USA Telephone: 1 978.929.2100 / 1 978.929.2100