Quality Certifications


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