Table Top Panels Exposed and FDA Class II Risks
In his latest reviews, Alex Fergus exposes many of the top red light therapy brands for their table top models.
Let's take a look at Alex's intensity measurements and how they compare to their advertised intensity.
So no surprise that again there is nearly a 100% difference across all these major brands. The advertised intensity claims may be inflated by about 2x of what the reality they are actually delivering at 6 inches away.
FDA Class II Risk vs Low Risk Photobiomodulation
The top panels like Joovv, PlatinumLED, and Mito Red Light are all FDA Registered (not FDA Approved) as Class II medical devices.
The Class II category is not for effectiveness, but a safety category for devices that have "moderate to high risk to the patient and/or user" compared to low risk Class I or general wellness devices. So the Class II registration is for products of higher risk ranking, not a badge of honor implying more benefits.
As well, most panels are FDA Registered under a loophole known as the ILY code, which is a code for heat lamps and other heating devices. The only indications they are legally allowed to market for are things like "temporary relief of minor aches and pains". Any advertised or implied benefits beyond minor pain relief or what they are registered for could be a form of medical malpractice.
And we know these companies may "accidentally" use the FDA logo on their website or marketing materials, which is generally forbidden for private companies to use the FDA logo which would falsely imply a direct affiliation with the federal agency.
Coupled with their high intensity output, the panels made by Joovv, Mito Red Light, and PlatinumLED should be considered as heating devices both in medical classification and function.
So, if you want to know the best moderate-risk Class II LED Heat Lamps with extra gimmicky features to buy, make sure to check out those companies.
Otherwise you can always visit GembaRed products for simple, low intensity, low risk, true photobiomodulation to support general wellness.