Confidence Through Proven Efficacy, Quality & Certification
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Automated laser diode fabrication
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Final laser diode validation and inspection
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All manufacturing processes are state-of-the-art
including sonic welding (shown above) and ISO Quality Assured.
Lexington's Quality Policy
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Lexington International and its management have adopted a formal and continuing program of review, evaluation and enhancement of our operations through the use of Quality Objectives. We have implemented this quality system to meet customer and statutory and regulatory requirements as noted in ISO 9001:2008 and 13485:2003
The Quality objectives will aid in the company’s ability to provide a commitment to customer service, quality products and related services. Lexington has adopted a Quality Policy Manual that incorporates these objectives. It is the commitment of Lexington International’s management and staff to align their daily work processes with this manual and to incorporate continuing improvement to meet our short and long term goals to become the world leader in Low Level Laser Therapy, advance the science of hair growth and hair care and to continue to build a customer centric company through a steadfast devotion to quality. We will use the framework of our quality system to comply with our customer’s requirements and to maintain the effectiveness of the quality management system. |
Regulatory Compliance Information
Quality Managment System
USA FDA Establishment Registration Number 3006182775
Product Certification and Approvals
Global Regulatory Representatives
Notified Body / Registrar / Certification Body
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
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ISO 9001:2008
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Internationally recognized standard for quality mangement and manufacturing. |
ISO 13485:2003
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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
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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 |
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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. |
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Lexington International, LLC is also a member of the Southeastern Florida Better Business Bureau and follows the BBB Code of Business Practices.
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Precautions
CAUTION: Never leave the HairMax LaserComb unattended when plugged into a power outlet. An electrical malfunction can result in a fire.
CAUTION: Do Not put strain on the cord when untangling or straightening it. Doing so can break the cord causing it not to work.
CAUTION: Never use magnifying optical instruments with the HairMax LaserComb. Their use with this product can cause temporary irritation to the eyes.
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.
CAUTION: Not recommended for use by men with Norwood Hamilton Classification I, II, Va, VI, or VII (See drawings on page 10 of the User Manual) because they are not likely to experience hair growth from using the HairMax LaserComb.
CAUTION: There is currently no validated scientific evidence supporting the safety and effectiveness of the HairMax LaserComb on women.
CAUTION: The safety or effectiveness of the HairMax LaserComb in men with Fitzpatrick Skin Types V and VI (see the description on these skin types on page 3 of the user manual) has not been evaluated.
NOTICE: If any malfunction occurs, do not attempt to repair it yourself. This appliance has no user-serviceable parts and is not to be opened or modified by the user. Use the HairMax LaserComb only for its intended use as described in this manual. Contact Lexington International LLC for repairs at 561.417.0200.
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
| 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 LaserComb is cleared by the FDA for The Promotion of Hair Growth in males with Androgenetic Alopecia who have Norwood Hamilton Classifications of IIa-V and Fitzpatrick Skin Types I to IV