A. The HairMax LaserComb® submission utilized a 510K medical device format and a double-blind, multi-center, sham device controlled study to prove efficacy. Based on this submission, In January 2007 the FDA cleared the HairMax LaserComb for marketing. (Please refer to the FDA Clearance Section of this site)
A. While there have been no formal studies conducted on the concomitant use of the HairMax LaserComb® in combination with other topical or systemic modalities, there are no contraindications to its use in this regard.
A. A brand new LaserComb Premium (with 9 laser beams) costs USD 545.00.
A. Because we are sure that your patients will be satisfied with their HairMax, we offer a generous money back guarantee: We Guarantee Satisfaction. Both HairMax LaserCombs® (Premium and SE) can be returned within 30 days less an 18% restocking fee of the purchase price. If the product is returned within 5 months (20 weeks), there will be a partial refund of 60% of the purchase price. This money back guarantee is effective from the date of delivery. Please note that only orders placed directly through Lexington International are eligible for this money back guarantee.
A. We have found that three times a week seems to be the optimal amount of usage. Using the HairMax LaserComb® more than three times a week has not been shown to accelerate hair growth.
A. User experience will vary. In general, there categories of user experience:
• 45% of users will see positive results after 8 weeks of treatment.
• 45% more users will see benefits from weeks 10-16
• 10% or the rest of the users will only begin to see subtle improvements (if any) after 16 weeks.
It is critical to success that your patients use the HairMax LaserComb® in the proper manner and for the proper length of time to see optimum results.
A. We do not provide samples of the HairMax. However, the fact that there is a money-back guarantee for the HairMax LaserComb® means that you can have your patients purchase the device for trial and have recourse if they are not satisfied with the results.
If you wish further information in this regard, please contact the Physician Information Center at
1-866-273-7795.
A. The HairMax LaserComb® can be used on wet or dry hair. Patients should use a sulfate free shampoo and conditioner. We manufacture a shampoo and conditioner that are sulfate free and designed to work well with the HairMax. These are described further on the website.
A. Using statistical modeling to arrive at an ‘n’ which would generate robust statistical information, 116 patients were entered into the study. Results of this study was a major contributing factor in the generation of the clearance to market the HairMax LaserComb®.
A. The clearance from the FDA was for males and a study has just been completed with female subjects. This will be the subject of a second filing.
A. Anecdotal reports have shown that the HairMax LaserComb® may help speed healing and graft patency, but there have been no formal studies carried out in this regard.
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