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The Theradome Laser Helmet is claimed by its manufacturers to promote healthy hair growth.

In this infographic, they claim it delivers energy to the skull at a concentration of 6.959 j/cm2 - presumably they are referring to 6.959 J/cm2.

Infographic from Theradome home page.

This is consistent with the research I have done (e.g. this unreferenced essay) that suggests around 6 to 7 J/cm2 is required for better hair growth.

However, they also claim in the chart from this video segment that the concentration is:

1.05 J/cm2

There web-site states:

The key to treating hair loss is lasers, but all lasers are not created equal. We use specially developed, high efficiency lasers that allow us to deliver the maximum amount of light and cover 582 cm2 of the 720 cm2 total scalp area in the average human head. We don't want to bore you with numbers, but with over 440 Joules per treatment and an optimised wavelength of 678 +/-8nm, each of the 80 lasers is precisely tailored for maximum hair growth.

Each treatment is 20 minutes long.

I have attempted to do the calculations to support the 6.959 J/cm2 claim, but have been unable to get these results.

Is there evidence (or even a calculation with the given data) that supports either of the concentration claims?

This question is re-posted from Physics.SE, as suggested by @BrandonEnright

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    Note: This questions is not about whether the laser treatment actually works, although that would make a good second question if people are interested.
    – Oddthinking ♦
    Jan 17, 2014 at 5:27
  • I have no knowledge of their product at all, but to transmit 7J/cm² over an area of 582cm² in 20 minutes requires about 3.5W combined laser output. That's not too much to fit into that helmet. (Compare the various dangerous 1W laser pointers on sale.)
    – Jens
    Jan 17, 2014 at 7:20
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    Also, power is not measured in joules...
    – Sklivvz
    Jan 17, 2014 at 7:25
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    That's right. Power is in Watts. A Watt is a Joule per second. If a treatment is 20 min, or 1200 seconds, and 443J then the 443J could be produced over 20 minutes at about 1/3 of a watt output. The input might need to be higher, or sometimes input power and output power are confused. Is this just a helmet with a few LEDs in it?
    – Paul
    Jan 17, 2014 at 8:42
  • So .. even if it is only 1 J/cm^2, just run it for 7 times as long to get 7 J/cm^2?
    – GEdgar
    Nov 15, 2015 at 23:57

1 Answer 1

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A 510(k) premarket notification must be submitted by device manufacturers to the US Food and Drugs Administration (FDA) to show a device is just as safe and effective as an existing device (referred to as a "predicate"].

Theradome's 510(k) for their laser helmet used the RF Midwest LLC MEP-90 Hair Growth Stimulation System as a predicate.

In Section 5, they claim:

The LH8O PRO utilizes laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment.

An inspection of the device itself, using tissue or paper over the lasers to see the beam profile, shows that there are 80 laser spots and lots of area outside the beam coverage that are NOT receiving any laser energy. There are more areas not receiving any laser energy than areas that are.

In the most common areas of hair loss that people want to treat, the temporal area (sides of the head) and the vertex (‘bald spot’ on the top of the head in back), it has very little laser light coverage and therefore leaves much of the scalp untreated.

Additionally, Theradome calculated the power output of their device, by measuring the energy coming from the laser that lands in a 1 square centimeter. Each laser only covers 1-2 square cm, and only these specific sized areas are receiving the full amount of laser energy. Those areas outside of the laser beam coverage are not receiving any laser energy. Therefore, the Theradome does not “deliver laser stimulation to the entire scalp” as claimed.

Based on this information, I believe that Theradome is allegedly attempting to mislead the FDA and general public, by filing their FDA 510K submission to the FDA with false and misleading information.

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  • Thank you for providing the 510(k) reference. I have incorporated it into your answer, and have done a fairly substantial edit, to make your key arguments clearer. Please double-check I have not misrepresented your points.
    – Oddthinking ♦
    May 3, 2014 at 0:28
  • You make a strong allegation of deliberate fraud, which deserves very strong evidence, but several problems remains with this answer. Primarily, it requires us to have access to the device to do the inspection to verify your claims. We can't tell if you are making it up. Further, we can't tell if the test you are proposing - laying tissue over the laser - is a fair one. If the lasers are divergently focused, and the lasers are far enough from the scalp, it might be completely covered.
    – Oddthinking ♦
    May 3, 2014 at 0:32
  • You argue that they measure the energy by looking at 1 square centimeter. You need a reference to support that.
    – Oddthinking ♦
    May 3, 2014 at 0:33
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    This answer is only correct if we assume that lasers only affect an area of skin they are directly targeted at, where in actual fact they heat the area they hit the most, but this heats nearby areas. Ambiguously worded, but so long as the lasers are spaced correctly, the scalp may all be affected by energy from the laser diodes. If you take 'laser stimulation' to mean that the laser is aimed at the entire scalp, the they misrepresented the facts, but if it merely means that the entire scalp is affected by energy from the laser, it could well be true.
    – Owen C. Jones
    Aug 1, 2014 at 11:29
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    Worth noting that there are existing dermatological treatments that use lasers, but do not aim these lasers to cover every inch of skin, rather they aim lasers at small sectored areas. Ironically, the best example of these is probably hair removal!
    – Owen C. Jones
    Aug 1, 2014 at 11:31

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