FDA Approved: Laser Hair Growth And LLLT Products

Do you know that according to studies, there are 21 million women and 35 million men who are suffering from hair loss?

Yes, and that number is still growing every day.

That is why more and more people are exploring different treatments that can effectively promote hair regeneration. And one popular option today is low-level laser therapy using laser combs and caps.

In this article, we will feature some of the best laser devices and other hair regrowth products recommended by experts that have Food and Drug Administration (FDA) clearances.

These products are proven safe and effective for men and women who suffer from hair loss problems. 

So what are you waiting for? Let’s go!

Are Laser Hair Growth Devices FDA Approved?

Numerous hair regrowth products in the market claim their effectiveness and efficacy. But some of them are still not proven. 

Luckily, some of the best laser devices for hair loss treatment have FDA clearances and are verified to be safe and effective for everyone to treat hair loss.

These products, such as HairMax laser devices, have undergone multiple clinical trials for decades to ensure their capability to promote the growth of human scalp hair.

Laser Hair Growth Device FDA Approvals

Here are some of the most popular and go-to options for HairMax laser devices used to treat hair loss and promote hair regeneration.

Medical Laser Device For Treatment Of Hair Loss

The HairMax LaserComb acquired its first-ever FDA approval in January 2007 for a medical laser device. It can be used to treat hair loss for men with androgenetic alopecia, also known as hereditary hair loss.

This HairMax laser phototherapy device features a hair parting teeth mechanism and 9 to 12 medical grade lasers for treating hair loss using a visible red light laser. 

It also comes with a rechargeable battery, charging stand, user manual, and 1-year laser device warranty.

Lasercomb For Home Use For Treatment Of Hair Loss

HairMax Lasercomb

This Hairmax LaserComb also has become the first FDA-approved laser comb in the market that can be used by men and women in the comfort of their homes.

HairMax laser devices provide healing light energy straight to your hair follicles to restore your hair’s natural growth cycle and halt hair shedding.

Treatment Of Androgenetic Alopecia

HairMax Laser Cap

One of the renowned HairMax laser devices used to treat hereditary and hormonal hair loss is the PowerFlex Laser Cap 272. This laser device was granted FDA clearance for its capability to treat androgenetic alopecia for men and women.

It utilizes its 272 medical grade diodes to nourish and stimulate hair follicles and helps regrow hair faster with its full scalp coverage.

Using HairMax PowerFlex Laser Cap for 15 to 30 minutes a day, 3 days a week, can guarantee you much healthier and fuller hair after a few months.

Do FDA Laser Hair Growth Products Work?

Laser devices that have FDA clearance can help reverse hair loss and stimulate hair follicles to grow hair.

Numerous clinical studies and trials have been made to prove their effectiveness and safety for us to use.

Clinical studies show that these laser devices can slow down and even reverse the effects of male and female pattern hair loss or androgenic alopecia.

And with their promising results, these laser products are doctor-recommended, receiving overwhelmingly positive reviews from their users.

One example of this is the PowerFlex Laser Cap. This laser phototherapy device speeds up hair regeneration and doubles the hair counts of some users for as short as 3 months.

What Other Hair Growth Products Are FDA Approved?

Although laser devices are a reliable hair loss treatment for men and women, there are still other products with FDA clearances that you can use to treat hair loss.


Finasteride is a well-known drug that can be prescribed by a healthcare professional to combat hair loss and promote hair rebirth. It is a DHT blocker that works to reduce the amount of hormone called dihydrotestosterone (DHT) in your body.

DHT is a male hormone that shrinks hair follicles, making them stagnant and scarred, thus stopping your hair from regrowing.

It has FDA clearances to treat several illnesses, such as benign prostate hyperplasia and androgenetic alopecia in men and women.


Minoxidil is an FDA-approved medication for the treatment of androgenetic alopecia. It is also the generic form of Rogaine, known for its ability to promote hair growth.

It is typically applied as a topical solution that can be spread evenly above the affected area of your scalp, where thinning of the hair usually starts. 

Which Hair Growth Products Are Not FDA Approved?

These FDA-approved products greatly help promote hair regrowth and resolve hair loss.

But do you know that some hair loss products may also be used, even without FDA clearances? It’s none other than home remedies. Some of these products are the following:

Hair Oil

Some might say that using olive and pumpkin seed oil as a hair oil treatment to prevent hair loss is effective. Several pieces of evidence show they can strengthen hair follicles and thus potentially stimulate hair regeneration.

But these accounts are still not verified nor recommended by experts.

And without further studies done on this, these treatment options cannot get any FDA clearance.

Saw Palmetto

Many of us consider using saw palmetto as an organic and healthier way of treating hair loss compared to laser therapy.

According to several pieces of research, saw palmetto blocks the effects of DHT. But this herb isn’t as well-studied as hair loss medications such as finasteride or minoxidil and may have side effects.

Even while some scientific evidence on saw palmetto is encouraging, it shouldn’t be considered a completely verified choice for treating hair loss at this time. That is why it still hasn’t gotten any FDA clearance.

Fact Checked by our Director of Dermatology We know that understanding how your skin and hair work can seem scary, so my team and I devote our time to thoroughly researching every single topic and product we write about. We hope you find our reviews helpful and informative.

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