Theradome Laser Review

At first glance, Theradome appears to be a promising contender, however, a closer look reveals problems.

Specifications

The unit sits on top of the head, and is operated by a built in battery that allows you to recharge it between uses. This is the first point that makes this look suspicious.

The reason the battery is a bad idea in this case is simple. The Theradome has 80 lasers. The power supply required to fully power 80 full strength lasers is considerable. With the resources that were obviously put into the marketing of this product, Theradome could have easily put in a power cord that would allow the lasers to fully do their job. Other devices in this range of lasers come with a sufficient power source.

The website shows it next to a clinical laser model; we think this is misleading. The clinical model it is positioned next to is, for certain, plugged into the wall to deliver full results. Batteries are insufficient to meet the needs of 80 lasers.

This lack of adequate power is likely the reason that many users have reported no results.

That being said, the device does have some interesting features. It comes with a vocal count that tells you how many treatments you've used the helmet for so far. While this is an interesting trick, it doesn't do much to convince us that the laser is worth the money.

Theradome return policy

If you choose to try the theradome for yourself, please be advised that the product comes with a registration form. If you do not fill this out and return it to register your product, on the same day you receive it, you will be ineligible to return it. Since the results of the machine are questionable, do not forget to register the product the day you get it.

Otherwise you won't be able to get your money back.

FDA Clearance - what it means

The Theradome has been granted FDA's 510(k) clearance. It is important to understand exactly what this means.

Technically, 510(k) is a status that means 'Substantial Equvalence.' What this means is that the device is basically-the-same-as a device marketed and sold prior to May 28, 1976. This is the date that a law was enacted making the requirement of FDA Approval necessary for certain devices.

Products that were marketed and sold prior to this date were grandfathered in and not subject to this approval process. Products appearing after that date, which are 'Substantially Equivalent' to a device grandfathered in, receive 510(k) clearance.

This is not the same as FDA Approval, which requires testing and proof of results.

In the Theradome FDA letter itself, the document basically says (on page 3) that Nonclinical Testing was conducted, which was performance testing; verifying that the machine functions according to the design.

This is not at all the same as saying it's actually effective at regrowing hair. It just says the device operates as it is intended. Results of growing hair were not a part of the testing - rather, does it work when you turn it on?

Several devices have gotten FDA 510(k) Clearance, and with good reason. This makes people think that the FDA has proven that it is capable of delivering results. It's very clever marketing, but it doesn't tell you anything about the results obtainable from the device.

This, along with Theradome's obnoxious return policy, are signs to watch out for. Very few people actually take the time to read these companies' FDA Clearances, much less actually understand what they mean.

Coverage

The coverage of this device is very good. The lasers are aimed at the head in a good pattern and both the top of the head and the sides are adequately covered.

Sitting atop the head does, however, mean that the lasers are rather locked to a particular location. This can lead to blotchy coverage, as each laser has its own location. This may tend to even out over multiple sessions though.

Conclusion

If this device were given enough power to do the job, this could be a highly rated machine. As it stands it is a poor choice. While it is without question the most attractive in the lineup, the poor results hold this back from being a worthwhile option.

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