Specializing in hair transplantation, hair restoration and hair transplants with hair loss clinics in New Jersey (NJ) & New York (NY)

The LaserComb consists of a hand-held low level laser device that promotes hair growth. The device provides distributed laser light to the scalp. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.

[Frequently Asked Questions about HairMax]

Performance Data

A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use the device three times per week on nonconcurring days for a total of 26 weeks. Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functioned as intended and the hair regrowth observed was as expected.

Substantial Equivalence

The LaserComb is as safe and effective as a combination of those predicate devices. The LaserComb has the same intended use of affecting hair growth as its preamendments hair growth predicate devices and its laser hair removal predicates. In addition, the LaserComb has the same general indications, i.e., treating baldness, and the same specific indication of promoting hair growth as its preamendments predicate devices. The LaserComb also has many of the same or similar technological characteristics as a combination of its predicate devices, including its red laser wavelength, its split beam laser delivery system, its comb component, and its audible timer. The technological differences between the LaserComb and its predicate devices, namely use of red laser to promote hair growth, do not raise new questions of safety or effectiveness for several reasons. First, the safety and effectiveness profile of that type of laser is well-established. Second, FDA's clearance of a red laser with virtually the same wavelength (for a cosmetic-type indication) confirms the favorable risk benefit ratio of red lasers, even when they are used for cosmetic-like indications. Finally, the clinical data summarized in the 5 10(k) notice confirms the safety and effectiveness of the LaserComb for OTC use in promoting hair growth in its intended patient population, despite those technological characteristics. For those reasons, the LaserComb satisfies FDA's substantial equivalence with respect to both the intended use and technological characteristics.

The clinical data demonstrates that the LaserComb is effective in promoting hair growth and does not present any safety issues. Therefore, the LaserComb satisfies FDA's substantial equivalence criteria. Thus, FDA should clear the device via the 510(k) notice containing clinical data.

• How do I use the HairMax LaserComb?
• How often do I need to use the HairMax LaserComb?
• Can I use the HairMax LaserComb more than 3 times/week to see faster results?
• How long will I need to continue treatment with the HairMax LaserComb?
• When can I expect to start seeing results from the HairMax LaserComb?
• Does it work on the entire head or only on the back?
• Can I use the HairMax LaserComb in conjunction with other treatments?
• I am just starting to thin, is it too soon to start?
• Can people of all ages benefit from using the HairMax LaserComb?
• Does the HairMax LaserComb work for women?
• Can I use the HairMax LaserComb if I have already had transplant surgery?
• Does your hair need to be clean to use the HairMax LaserComb?
• How often do you need to wash your hair when you use the LaserComb?
• Where can I purchase one?

How do I use the HairMax LaserComb?

To turn on the HairMax LaserComb press the “power” button and then the “laser” button on the front of the unit. Next, place the LaserComb flat on your head using the two rows of teeth. Rather than constantly moving the HairMax LaserComb through your hair (as you would with a regular brush or comb), you will use what we like to call the “glide” method by placing the HairMax LaserComb on a specific spot on your head and gently gliding it back 1/2 inch each time the audible four-second beep occurs. Move from the front of your hairline to the back of your head and then repeat the process moving in the opposite direction. The “glide” method is the best way to ensure that the LaserComb will be as effective as possible for you. [Top]

How often do I need to use the HairMax LaserComb?

It is recommend that the HairMax LaserComb be used 3 times per week, 10-15 minutes per treatment for optimal results. [Top]

Can I use the HairMax LaserComb more to see faster results?

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 the benefits. [Top]

How long will I need to continue treatment with the HairMax LaserComb?

Hair care treatment, as with the treatment of any condition, is an ongoing process. For this reason, it is imperative that, to keep seeing positive benefits from the HairMax LaserComb, you use it as indicated on a consistent basis. You can miss a day here and there and be alright, but all in all, if you do not use the product as recommended, there is a strong possibility that you will not see desirable results or you will regress to where you were prior to using the HairMax LaserComb. [Top]

When can I expect to start seeing results from the HairMax LaserComb?

User experience will vary. In general, there are three categories of user experience: 45% of users will see positive results after 8 weeks of treatment. Another 45% will see benefits from weeks 10-16. The last 10% of users will begin to see subtle improvements (if any) after 16 weeks. [Top]

Does it work on the entire head or only on the back?

The HairMax LaserComb may improve the appearance of the entire head: back, front, top and sides. [Top]

Can I use the HairMax LaserComb in conjunction with other treatments?

Yes, the HairMax LaserComb works well as both a stand alone treatment and in conjunction with other treatments. [Top]

I am just starting to thin, is it too soon to start?

It is never too soon to start. The better the initial condition of your hair, the better your results with the HairMax LaserComb can be. The HairMax LaserComb treatment should be incorporated into your daily preventative maintenance routine, much like brushing everyday to maintain healthy teeth and gums. [Top]

Can people of all ages benefit from using the HairMax LaserComb?

Studies have shown that laser phototherapy (LPT) is effective in people ages 18 and older. For people under the age of 18, we recommend you consult your physician prior to using the HairMax LaserComb. [Top]

Does the HairMax LaserComb work for women?

At this stage the HairMax LaserComb is only indicated for male use. A clinical study for use in females will be completed and submitted to the FDA for this indication in the near future. [Top]

Can I use the HairMax LaserComb if I have already had transplant surgery?

This practice is encouraged by an increasing amount of hair transplant surgeons worldwide. The HairMax LaserComb has been shown to decrease the recovery time in hair transplant patients, and also to increase the look of the transplanted hairs in a positive manner (making them appear thicker, fuller, and healthier). The teeth of the HairMax LaserComb are even removable making immediate use after surgery possible. [Top]

Does your hair need to be clean to use the HairMax LaserComb?

It is recommended that you use the HairMax LaserComb on a clean scalp so that the laser can effectively improve the appearance of your hair without being hindered by oils, dandruff, etc. The reason for this is to prevent product buildup from blocking the laser light. However, you can also address this by cleaning your LaserComb with a damp cloth before and after each use. [Top]

How often do you need to wash your hair when you use the LaserComb?

It is recommended that you wash your hair at least three times a week. This way the HairMax LaserComb can work effectively without the possible blockage which comes with having excessive oil buildup on the scalp or excessive dandruff. However, this is not imperative for the HairMax LaserComb to be effective; you can also address this by cleaning your LaserComb with a damp cloth before and after each use. [Top]

Where can I purchase one?

Simply contact us at the office or send us an email. [Top]