Confidence through Efficacy
LNE innovations
Confidence through Efficacy
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.
Quality and Certifications
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
- Certyficate of Analysis I
- Certyficate of Analysis I I
- Certificate to Foreing Government
- CB Scheme Certificate – Prima and Ultima
- Certificate ISO-9001 June 2 2017
- Certificate ISO-13485 June 2 2017
- HairMax LaserBand FDA Clearance K142573
- Letter to File – Prima & Ultima Devices – January 2014
- MHRA Decision
Europe * Emergo Europe, 2514 AP The Hague, Netherlands. http://www.EmergoGroup.com
ISO
The HairMax Laser Devices maintain ISO 13485:2003 and 9001:2008 certification and is audited by: InterTek Testing Services 70 Codman Hill Road Boxbourough, MA 01719 USA Telefon: 1 978.929.2100 / 1 978.929.2100