Theradome_FAQ

Will I Benefit From Using The Theradome™ LH80 PRO?

In clinical studies, ALL participants benefited from using the Theradome™ helmet and experienced one or more of the following:

  1. A minimization and slowing down of hair loss;
  2. A thickening of hair follicle size for existing hair;
  3. New growth of healthy hair.

How Long Until I See Results?

Step 1: The first step is minimizing hair loss, which typically occurs 4 – 18 weeks into Theradome hair growth treatment.

Step 2: Reversing miniaturization is the next step to getting thicker, fuller and more lustrous hair. This typically occurs within 18 – 26 weeks of continued use.

Step 3: The final step is renewing your hair growth, which typically begins within 26 – 52 weeks of starting treatment. Keep in mind that individual results may vary.

How Long Will I Need To Continue Treatment?

Laser hair therapy is similar to exercise – you have to integrate it in your lifestyle to continue enjoying the benefits. Once you achieve the desired results, we recommend a maintenance treatment schedule of 1 – 2 sessions per week.

Are There Potential Side Effects From Using The Theradome™?

There are no known side effects from using the Theradome™ LH80 PRO.

How Do I Use The Theradome™?

It’s very easy. The product has a simple, one button operation which uses audio commands to inform you if the battery is low, how many treatments you’ve completed since your Theradome™ purchase, how many minutes are left in a session, and if your laser helmet is experiencing any technical issues.

 Is Theradome™ FDA-Cleared?

Yes. On June 14 th 2013, the Theradome™ LH80 PRO became the first wearable device in the world to be FDA-cleared for over-the-counter (OTC) use. Our official FDA clearance letter can be seen on the FDA website at

https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122950.pdf .)

Can I Use The Theradome™ To Thicken My Hair?

Yes. The Theradome™ can increase the thickness and density of hair follicles.

How Do I Determine If Theradome™ is Right For Me?

The Theradome™ laser helmet is designed to work with most stages of hair loss but the earlier one starts treating, the better the outcome. There are several scales to help determine the stages of hair loss in women. The most common– the Savin Scale– measures overall thinning as well as density. For men, the Norwood scale is most commonly used. Please see the diagrams below to determine which stages best identify your situation.

Hair loss stages Theradome treats effectively

What Is The Best Way To Track My Treatment Progress?

Keeping a visual record is the easiest and most effective way of tracking your progress. Take photos of your hair before you begin treatment and then at regular stages while using your Theradome™. For best photographic results and to gain a clear representation of your hair growth and overall thickness, please see our online Before and After Photo Guide.

 

MEDICAL QUESTIONS

Can I Use Theradome™ Along With Other Hair Loss Treatments Such As Rogaine, Propecia (Finasteride) Or Dutasteride?

Yes, adding LLLT Theradome TM treatments to your current hair loss medication(s) will increase the rate and quality of your hair recovery. Please note that women cannot take Propecia (finasteride) or dutasteride.

Since these medications are known to cause shedding, you should NOT discontinue their use once starting LLLT treatments. Please consult your physician to initiate a plan that will gradually decrease the dose of these medications over the course of 3 to 6 months.

Can I Use The Theradome™ If I Have Had A Hair Transplant?

The nation’s top hair restoration experts, such as Bosley Medical and Hair Club for Men, provide the Theradome™ to their patients. It works very well with pre-op patients and with those who are post-transplant. Transplants cause trauma to nearby hairs. Using the Theradome TM will alleviate these effects by providing extra energy and minimizing shock loss. In essence, Low-Level Laser Therapy (LLLT) assists the growth of newly planted follicles by: 1) accelerating the healing process; 2) reducing redness/inflammation; 3) decreasing discomfort; and 4) encouraging transplanted hairs to grow faster.

Is It Ever Too Early To Use The Theradome™ LH80 PRO?

No, it is never too early to use the Theradome™ laser helmet, as it helps with the various stages of hair loss and will add volume to your hair, even if you haven’t yet experienced major hair loss. The Theradome TM LH80 PRO can also be used as a preventative measure or simply for maintenance of healthy hair.

What Is The Difference Between Lasers & LEDs For Hair Growth?

Laser lights travel in alignment, forming coherent beams that maintain full intensity and power. LED light, like a light bulb, spreads out in all directions, rapidly losing penetrative power as it travels. Many inferior so-called hair growth devices are made with LEDs, which are much less expensive to make, and hence do not have adequate power to penetrate the base of hair follicles and reverse hair loss. The Theradome™ is the strongest and most powerful OTC device out on the market today.

Why Is Theradome™ a Better Option Than A Laser Comb Or Laser Hood?

Not only is the Theradome™ more convenient with its cordless, hands free operation, but our 80 lasers penetrate the scalp, reaching the base of hair follicles and depositing an energy dosage optimal for stimulation with a 20-minute treatment time. Combing your hair with a laser comb for 20 minutes targets different areas of your scalp and can never achieve effective hair-follicle stimulation, since no area is exposed for more than an average of 4 – 30 seconds . The Theradome™ has rubber pegs, which are designed to part the hair to ensure maximum exposure of the scalp.

Can The Theradome™ LH80 PRO Cause Cancer?

Low-Level Laser Therapy (LLLT) is safe, has been around for decades and does not produce ionizing radiation. Over 1,500 scientific peer-reviewed papers support its benefits for biostimulation. The lasers of the Theradome™ LH80 PRO penetrate the scalp to the base of both vellus and terminal hair follicles and do not penetrate the brain or skull. The Theradome™ LH80 PRO is cleared by the FDA for safety and efficacy.

Patients that have an Ommaya reservoir under their scalp need to consult their physician before undergoing LLLT for hair growth. Additionally, scalp cancer patients should refrain from using the Theradome, as it can activate the growth of both healthy and unhealthy cells.

If I’m Being Treated For Cancer, Can I Use The Theradome™?

Anyone currently undergoing treatment for cancer should check with their physician regarding using the Theradome™ LH80 PRO. Our laser helmet can usually be used outside of the active cancer treatment window. Once cancer treatment has ended, normal usage of the Theradome™ LH80 PRO can be resumed. However, please check with your physician if you have ever been diagnosed with scalp cancer.

It should be noted that cancer treatments are known to cause hair loss and negatively impact hair quality when growth resumes. After treatment, many recovering cancer patients that have used the Theradome™ LH80 PRO for hair restoration have experienced a dramatic improvement in the quality of their hair.

Do I Need A Prescription To Use The Theradome™ LH80 PRO?

No, this powerful and technologically advanced device is and over-the-counter product.

Are There Any Medical Conditions That May Interfere With The Effectiveness Of Low- Level Laser Therapy (LLLT)?

Before considering any hair growth treatment, properly diagnosing the cause of your hair loss with a physician is essential. If you have any underlying medical conditions such as thyroid disease, anemia, are taking any medications, or if you have any possible scalp conditions such as psoriasis, please visit your doctor to address these medical concerns. Any underlying medical conditions can be the cause for seeing slower than average results with your Theradome™ LH80 PRO.

Why Is An FDA 510 (K) Clearance Important?

The purpose of the FDA 510 (k) is to demonstrate the SAFETY and EFFECTIVENESS of a medical device. In order to protect people from false claims and dangerous medical equipment, the United States requires rigorous testing that includes laboratory and clinical trials to prove both safety and effectiveness. Data derived from these studies, which must meet specific requirements, are submitted to the FDA via a 510 (k) submission form for review and clearance to legally market the medical device in the United States.

An FDA 510 (k) clearance allows consumers to distinguish between proof and false claims concerning safety and efficacy. Only after gaining clearance– the acknowledgement that the device is safe and effective for public sale– is an FDA 510 (k) clearance granted to the manufacturers of a medical device.

It is very important that any device you consider for purchase has an  FDA-cleared 510(k). We advise you to visit the FDA.gov website to check for a product’s FDA compliance status before reaching a decision.

 

THE THERADOME™ LASER HELMET

How Many Times A Week Should I Use The Theradome™?

We recommend using the Theradome twice-a-week for 20 minute-sessions.

When Is The Best Time To Use The Theradome™?

The ideal time for treatment is right after a shower after towel drying your hair. The Theradome™ has rubber pegs, which are designed to part hair to ensure maximum exposure of your scalp. We do not recommend conducting treatments on soaking wet hair.

Can I Use The Theradome™ Every Day?

Treatments were cleared by the FDA for twice-a-week usage and we recommend following this regimen. Should you choose to go beyond the twice-a-week recommended usage, please allow a minimum of 12 – 24 hours of rest in between treatments.

Will The Lasers Reach My Scalp If I Have A Somewhat Full Head Of Hair?The Theradome™ has 80 lasers and rubber pegs that allow parting of thicker hair. We recommend using your Theradome™ after you get out of the shower and towel dry your hair.

How Much Does The Theradome™ LH80 PRO Weigh?

It weighs slightly less than 16 ounces and is comfortable to wear.

I’m Worried That The Theradome™ Won’t Fit My Head. Do I Need To Worry About The Helmet Size?

The Theradome™ has been designed to fit 98% of the population! The 2% with size issues are generally people with smaller heads. For these customers, we provide foam pads to ensure a correct fit. So regardless of your head size, you can order your Theradome™ with confidence that it will fit comfortably while you complete treatment.

How Do I Charge My Theradome™ LH80 PRO?

Connect the USB cable end to the AC adapter. Attach the micro-USB cable end to the connector located under the master switch. Plug the adapter into an outlet.

While your helmet is connected to the charger, the master switch will slowly change colors. This indicates that the helmet is charging. When the color becomes solid green for at least 10 seconds, your Theradome TM is fully charged and ready for use.

To extend the Theradome battery life, only recharge it after you have received a “Battery Low” message. You will still be able to complete your current treatment session after hearing this warning. Please let the helmet fully charge before your next treatment. Rest assured that Theradome’s circuitry prevents any risks of overcharging.

My Skin Is Dark; Can I Still Use The Theradome™ LH80 PRO?

The Theradome™ LH80 PRO is FDA-cleared for Fitzpatrick Skin Types 1 – 4. Due to a limited number of subjects, data for skin types 5 – 6 are currently unavailable. Ideal for a variety of skin types

The Theradome™ Fits Too Loosely– Is It Supposed To Be Loose?

Foam pads are provided for a comfortable fit, but a loose fit isn’t a cause for concern. For best results, we’ve designed a comfortable fit enabling customers to SIT STILL during treatment. Activities such as browsing the Internet, watching TV or reading are perfectly compatible, but vigorous physical activity should be avoided during each 20-minute treatment session.

Are Your Lasers Dangerous?

The lasers used by Theradome™ are of a red color, part of the visible spectrum of light, and not intense enough to cause damage to the eyes. Because the lasers are very bright, a three-step safety system has been implemented that prevents laser light from accidentally shining into your eyes. If you intentionally defeat this system, the lasers will still cause no harm, but we do not recommend staring into your Theradome™ on purpose.

How Long Does It Take To Charge The Theradome™?

The device will be fully charged in 3 hours or less.

 

CARE, HOUSEKEEPING & USAGE

How Do I Clean My Theradome™?

The Theradome™ can be cleaned by simply wiping the inside and outside with a cloth to remove any oils or residue. You do not need a special cleaner.

Can I Share The Theradome™ With Others In My Household?

Yes, the Theradome™ can be used by multiple family members, but the helmet’s counter will only track the total number of treatments – it cannot differentiate between users.

What Type Of Shampoo Should I Use While Using The Theradome™?

Since hair loss is often associated with inflammation and fungus, we recommend shampooing with medicated and anti-fungal shampoos to clean the hair, reduce inflammation of the scalp and kill any fungus loads.

Should I Shampoo Daily?

It is recommend to shampoo every 2 or 3 days.

Are Conditioners Useful?

While shampoos are designed for the scalp, conditioners are designed for the hair. You can use any conditioner that softens your hair.

What Is The Best Way To Pack My Theradome™ When I Travel?

We recommend using our carrying case, which protects the Theradome™ from any damage while traveling and keeps all of its accessories together.

 

WOMEN’S HEALTH

After My Pregnancy, My Hair Became Brittle And Started To Thin Out – Can Your Product Help?

Yes, provided you are done with breastfeeding, you can start using the Theradome™ to regrow and thicken your hair.

I Am Breastfeeding – Can I Use Your Product?

No. It is not recommend to use the Theradome™ helmet while breastfeeding.

I Am A Mature Woman With Damaged And Thinning Hair – Can You Help Me?

Yes, the Theradome™ can definitely help. With proper and compliant use, you will notice a decrease of hair loss and shedding. In the following months, your thinning hair will become thicker, healthier and more lustrous.

I Am Pregnant – Can I Use Your Product?

No. It is not recommended to use the Theradome™ helmet while pregnant, unless specifically approved by your physician.

Is The Electrical Adapter For The Theradome Compatible With All International Electrical Outlets?

Our electrical products are UL-Listed, manufactured in compliance with U.S. standards, and can operate with electrical outlets between 100 – 240 V (50 Hz / 60 Hz).

FDA 510(K) K122950

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