Quality Certifications, Management System & Regulator Requirements - HairMax
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HairMax Free Shipping

on Laser Devices

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HairMax Free Shipping

on Laser Devices

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US : 1 (800) 9REGROW
INTL: +1 (561) 417-0200

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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.

hairmax laser diode inspection

Final laser diode validation and inspection

Hairmax laser diode fabrication

Automated laser diode fabrication

hairmax laserband 82 distribution

Pallet of LaserBand 82

Hairmax Laserband 82 glow

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

Certificate of Registration Icon

ISO 13485:2017
(Certificate of Registration)

Certificate of Registration Icon

ISO 13485:2017
​​​​​​​(Certificate of Registration)

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