Certifications


Product Quality and Certification

Together with our principal and manufacturer, we are dedicated to providing products that consistently meet the requirements and expectations of our customers. The application of a rigorous Quality Managment System, including a commitment to comply with regulatory requirements ensures the highest possible environmental and safety standards.

 

Registrar

Intertek 2000   Intertek 2003

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

 

Hair Growth Laser, Laser Brush, Reverse hair loss, Hair Restoration for men, Thinning hair

Automated laser diode fabrication

FDA Cleared Laser comb, Laser Hair Therapy, FDA Cleared for Promotion of Hair Growth, Hair Loss Treatment

Final laser diode validation and inspection

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

Click here to view the HairMax LaserComb Safety Video Presentation

US FDA Good Manufacturing Practices (GMP) – We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations

USA FDA Establishment RegistrationNumber 3006182775

 


Product Certification and Approvals

Product Certification and Approvals

Australia – ARTG Certification
HairMax LaserComb
Korea – KFDA Cleared
HairMax LaserComb
Brazil – Official Document of Recognition
HairMax LaserComb Pg. 1
HairMax LaserComb Pg. 2
Canada – Medical Device License
HairMax LaserComb
Europe – Declaration of Conformity
HairMax LaserComb
United States – FDA 510(K) cleared devices
HairMax LaserComb
Russia – Official Document of Recognition
HairMax LaserComb

 

Compliance Certification Services

HairMax LaserComb has earned CE certification for conformity with the essential health and safety requirements set out in European Directives. The CE marking refers to the safety of a product and CE certification is another major clearance by the LaserComb as being safe for use by consumers. The CE certificate has been awarded by Compliance Certification Services (CCS).

 


Device Patents