Confidence Through Proven Efficacy, Quality & Certification
 
Lexington's Quality Policy 
 
The management and staff of Lexington International LLC. are dedicated to providing products that consistently meet or exceed the requirements and expectations of our customers through the application of a rigorous Quality Managment System, including a commitment to comply with regulatory requirements. We seek continual improvement in all areas of the organization, including the effectiveness of the quality management system, and will maintain a focused commitment to total quality and a no-compromise position on the highest possible environmental and safety standards.

 

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
 
Regulatory Compliance Information
 
Quality Managment System
 
 
USA FDA Establishment Registration Number 3006182775
 
 
Product Certification and Approvals
 
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
 

Intertek 2000
ISO
9001:2008

Internationally recognized standard for quality mangement and manufacturing.

Intertek 2003
ISO 13485:2003

 Internationally recognized standard for quality medical device manufacturing.
 
Lexington International, LLC. is a ISO 9001:2008 and ISO 13485:2003 certified company following GMP (Good Manufacturing Practices). Certification to ISO standards assures customers that Lexington International operates a Quality Management System in accordance with the International Standards Organization. Lexington undergoes regular audits to maintain certification and the commitment to quality.
 
Device Patents
 

Country

Patent Number

Date
Australia

 780927

  April 28, 2005
China

 ZL 00 8 18391.0

  July 4, 2007
Korea

 10-0761092

  September 17, 2007
Macau  J/000151  June 7, 2007
Singapore  200204863-5  October 29, 2004
USA  6,497,719  December 24,2002 
  (Reissued March 18, 2008)
USA  7,201,764  April 10, 2007
Japan  4153697  July 11, 2008
 


In addition, the 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. CE certificate has been awarded by Compliance Certification Services (CCS). Lexington International, LLC is also a member of the Southeastern Florida Better Business Bureau and follows the BBB Code of Business Practices.



 
Warnings and Cautions
 

WARNING: Do not stare directly at the red laser light or its reflection in a mirror because it can temporarily irritate your eyes. If you stare at the light for too long you could harm your eyes. Also, never use a magnifying glass when using the HairMax LaserComb because it can cause temporary irritation to your eyes.


WARNING: Keep the HairMax LaserComb out of the reach of children.


WARNING: Do not drop the HairMax LaserComb in water because you may get an electrical shock. If the HairMax LaserComb gets damaged by water, contact Customer Service toll-free at 1-866-527-3726.


WARNING: If the cord is damaged on the HairMax LaserComb don’t use the device because you could get an electrical shock. If the cord gets damaged, contact Customer Service toll-free at 1-866-527-3726.


WARNING: Do not use the HairMax LaserComb near any heated surfaces because this could cause the device not to work properly and may cause an electrical shock. Contact Customer Service toll-free at1-866-527-3726.

CAUTION: If you are taking any medications or products that make you sensitive to light, you should test the HairMax LaserComb to make sure you do not have a reaction. Some of the things that can cause increased sensitivity to the HairMax LaserComb could be medicines for colds, allergies, pain medicine and drugs to treat infections. To test the HairMax LaserComb for sensitivity, turn the device on, hold the device on one spot, shining the light on your forearm. After two minutes, turn the device off and set aside. Look at the spot where you held the laser light over the next five minutes. If you see any reaction such as redness or rash, do not use the HairMax LaserComb and contact Customer Service toll-free at 1-866-527-3726 to return your product and get a refund.


CAUTION: Only use the HairMax LaserComb as directed. Don’t try to change the way the HairMax LaserComb operates. Changes may result in harmful laser exposure. Contact Customer Service toll-free at 1-866-527-3726 for repairs.


CAUTION: Never use acetone or other solvents on any part of the HairMax LaserComb. Use of solvents on the window can block the laser light from coming through.


NOTICE: If any malfunction occurs, do not attempt to repair the HairMax LaserComb yourself. This appliance has no user-serviceable parts. Use the HairMax LaserComb only for its intended use as described in this manual. Contact Customer Service toll-free at 1-866-527-3726


Electrical Safety

Basic safety precautions should be observed when using this, or any other electrical device, especially when children are present.

DANGER: Keep away from water. Contact with water may result in an electrical shock.

To reduce the risk of hazard by electric shock:
Always unplug the HairMax LaserComb from the power outlet immediately after using.
Do not use while bathing.
Do not place or store the HairMax LaserComb where it can fall or be pulled into a tub or sink.
Do not expose the HairMax LaserComb to running water, or drop into water or any other liquid. 
If the HairMax LaserComb falls into water, unplug it immediately from the power outlet.
Do NOT reach into or touch the water.
If using the HairMax LaserComb near water, the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended.
 
The following laser safety label can be found on the
  HairMax LaserComb® on the underside of the product handle
 
HairMax LaserComb warning label
 
 
 
Customer Satisfaction is of Primary Importance
       Clinically Proven to Promote Hair Growth*
       Greater than 90% User Satisfaction Reported
       Patented and Manufactured in the USA
       ISO Quality Assured
       Proud Members of the Better Business Bureau
*The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.