HairMax LaserComb - Information for Healthcare Professionals

Introduction

Background

The HairMax LaserComb Lux9 is indicated to treat Androgenetic Alopecia and promote hair growth in males and females*.

The HairMax® LaserComb was designed and developed in Australia in the 1980’s. The founding director of Lexington International, LLC, Henry Pearl was a pioneer in the use of laser technology at a leading skin and hair care clinic and research center in Sydney, Australia. The company was established in the U.S.A. in 2001 to develop and market this revolutionary device and in 2002 the HairMax LaserComb was introduced.

FDA Submission and Clearance

June 2011 - Marketing Clearance granted for the HairMax Lux 9 for treatment of AGA in females

May 2010 - Marketing clearance granted for 3 new models of the HairMax by the FDA for treatment of AGA in males

*HairMax LaserComb Professional 12 – 12 lasers

* HairMax LaserComb Lux 9 – 9 lasers

*HairMax LaserComb Advanced 7 – 7 lasers

January 2007 - Marketing clearance granted by the FDA

January 2006 - 510K filing for the HairMax submitted to FDA.

Key Clinical Study

The results of the key clinical study performed in 2006 with the HairMax LaserComb which led to this FDA Clearance to market in 2007 was published in the May 2009 Issue of Clinical Drug Investigation.

For detailed results of this study, Please Click Here

Official Indication

*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.

Strict Quality Standards

The HairMax LaserComb is manufactured strict quality control standards and complies with all applicable laser safety standards.

The HairMax LaserComb is the only home use laser phototherapy medical device with FDA marketing clearance for the treatment of certain classes of Androgenetic Alopecia in males and females*.