Clearance Process
Q. Is the HairMax® LaserComb approved by the FDA?
A. The HairMax LaserComb submissions utilized a 510K medical device format and were designed as double-blind, multi-center, control device studies to prove efficacy. Based on this submission, In January 2007 the FDA Cleared the HairMax LaserComb for marketing. HYPERLINK “http://www.hairmaxpro.com/fda.html” (Please refer to the FDA Clearance Section of this site) for the treatment of AGA in both males and females.*
Use in Females
Q. Can the Hairmax LaserComb be used on both male and females.
A. The HairMax LaserComb is indicated for the treatment of AGA in both males and females*.
Clinical Study on Efficacy
Q. Have the result of the clinical trial been published?
A. The results of the key clinical study performed with the HairMax LaserComb which led to FDA Clearance to market in 2007 was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia*, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc.
For detailed results of this study, Please Click Here
Concomitant Usage
Q. Can the HairMax be used with other modalities?
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.
HairMax Models
Q. What is the difference between the 3 HairMax LaserComb models?
A. All HairMax LaserComb models deliver the same laser energy, the main difference in the number of laser diodes contained in the devices which effects treatment time. The more laser diodes contained, the less treatment time is required. There are also small differences in the features of the devices. The HairMax Professional 12 is an ideal choice for professional practices for incorporation into treatment regimens for AGA. Click here for a quick model comparison.
The device is an excellent practice builder when carried in the office. Learn More.
Cost
Q. How much does the HairMax LaserComb cost?
A. The HairMax LaserComb Professional 12 costs USD 545.00, the HairMax LaserComb Lux 9 costs USD 495, and the HairMax LaserComb Advanced 7 costs USD 295.00
Efficacy
Q. What happens if the HairMax LaserComb does not appear to have efficacy on an individual patient?
A. Because we are sure that your patients will be satisfied with their HairMax LaserComb, we offer a money back guarantee: If the product is returned within 5 Months (20 Weeks), there will be a 20% restocking fee applied. 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.
Optimal Usage
Q. Will results improve when the HairMax LaserComb is used more frequently than 3 times a week for 8- 15 minutes?
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.
Results
Q. How long before the patient starts to see results from use of the HairMax LaserComb®?
A. User experience will vary. In general, there categories of user experience:
- Many users will see positive results after 8 weeks of treatment.
- More users will see benefits from weeks 10-16
- A minority of 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 as directed and for the proper length of time to see optimum results.
Samples
Q. How do I get some of these devices to try on my patients?
A. We do not provide samples of the HairMax LaserComb. 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 Professional Services at
1-866-273-7795.
Shampoos and Conditioners
Q. Can the HairMax LaserComb be used on wet hair and are there any shampoo recommendations that go along with the device?
A. The HairMax LaserComb can be used on wet or dry hair. Patients should use a sulfate free shampoo and conditioner. We offer the HairMax Healthy Hair line of hair care products which do not have irritants such as sodium lauryl sulfate and will make your hair more conducive to the use of the HairMax LaserComb. Learn about HairMax Healthy Hair Care products
Use with Hair Transplants
Q. Is the HairMax LaserComb is a good adjunct to hair transplant/surgical procedures?
A. A number of hair transplant surgeons have reported that use of the HairMax LaserComb in hair transplant patients may decrease shock fallout of native hairs, enable quicker return to normal pigmentation of scalp, and promote faster growth cycles of the transplanted hair follicles, but there have been no formal studies carried out in this regard to validate these findings. (The teeth of the device are removable making immediate use after surgery possible.)
Ordering
Q. How do my patients obtain the HairMax LaserComb?
A. The HairMax LaserComb is available for purchase by your patients by accessing the web site: www.hairmax.com or by calling 866-527-3726, 24/7.
Distribution
Q. How do I obtain information on carrying the HairMax LaserComb in my office
Click here for details on distribution opportunities.
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