Quality Certifications - OLD
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, 2514 AP The Hague, Netherlands. http://www.EmergoGroup.com
Registrar
The HairMax Laser 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
ISO 13485:2017
(Certificate of Registration)
ISO 13485:2017
(Certificate of Registration)