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FDA Clearance, Laser Hair Loss Devices and Hair Regrowth

A minor controversy is brewing in the US over claims made about a device which is sold to help to reduce hair loss.

food-and-drug-administration-usa-fdaIt concerns a special helmet named the Capillus82 which uses a proven technology called low level laser therapy (LLLT) to stimulate follicles on the scalp. As one of the newer players on the market, the Capillus82 was granted FDA (Food and Drug Administration) approval based on the fact that it was broadly similar to existing models that had already been approved by the government body.

Intended for home use

Designed for use on people with the genetic conditions male pattern baldness and, in women, female pattern hair loss, the Capillus82 is intended for home use, and comes with a price tag of $799 (around £602). The maker claims it helps to reduce progressive hair loss and make new hair grow and has even announced that in a small-scale test of people with female pattern hair loss, one of the three models it sells showed a 51 per cent mean increase in hair counts compared to patients who had used a dummy device. No mention was made, however, of whether or not any of the 44 volunteers in the study were using other hair loss treatment products as well.

The reason the maker of Capillus82 is in the news this week is because America’s National Advertising Division (NAD) – a watchdog for truthfulness and accuracy in advertising – has apparently written to it to recommend that it stops using certain claims in its advertising. According to legal website Lexology.com, the organisation wants Capillus82 to discontinue its claims that its device is clinically proven to regrow hair.

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The article in Lexicology.com says that Capillus proffered no clinical trial data on the Capillus82 to support certain claims it makes. The website’s writer asserts that in a key sentence of the decision, the NAD wrote: “While the advertiser established to the FDA’s satisfaction that the Capillus82 is substantially equivalent to other devices cleared by the FDA to promote hair growth and, as a result, it can be marketed for its intended use, the cited studies are not a good fit to support the challenged claims that Capillus82 is clinically proven to regrow hair.”

LLLT devices are not generally regarded as a solution to genetic hair loss in their own right, but they can form an important part of a wider package and fall into the category of ‘hair growth boosters‘.

Indeed, Belgravia clients seeking hair loss treatment are offered the use of a different LLLT device alongside what are considered to be “primary” treatment solutions. These are finasteride 1mg and minoxidil and they are the only treatments for androgenetic alopecia that are presently approved by both the UK’s MHRA and the FDA.

The once-a-day DHT-blocking tablet finasteride 1mg can be taken by medically-suitable men aged 18 and over only, whilst recommended formulations of high strength minoxidil are applied directly to the scalp in order to promote regrowth in both men and women.

Hairloss treatment Male Pattern Baldness LasercombThe device offered to Belgravia clients is a HairMax LaserComb. HairMax was the first company to gain FDA clearance in relation to an LLT device for hair loss, and is considered a leader in its field. Unlike other products on the market, the LaserComb has a patented combing action which allows for the hair to be parted so that the laser beams can get straight to the scalp rather than the hair.

When used as part of a tailored treatment course, results can be significant, and the LaserComb – which costs just under half the price of the Capillus82 – is often provided to Belgravia clients free of charge when a 12 month treatment course is purchased in advance.

How LLLT works

Scientific studies on cell cultures have shown that laser light energy penetrates soft tissue and increases the action of adenosine triphosphate (ATP), a molecule that is a major carrier of energy from one reaction site to another in all living cells. The best known example of light converting into chemical energy is photosynthesis, where plants are fed via light converted into chemical energy to improve and speed up growth. The LaserComb works in the same way, by helping to speed up hair growth and strengthening the existing hair.

It was cleared by the FDA back in 2007, having provided sufficient evidence following a clinical trial that showed the device effectively helps to prevent hair loss while ensuring safety.


The Belgravia Centre Hair Loss ClinicThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.


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