Here’s How to Identify a Non-FDA-Cleared Cap Before It Wastes Your Money and Damages Your Hair
Zombies. Zombies everywhere – and by zombies we mean the worst laser caps for hair regrowth.
That’s what we call this recent crop of non-FDA-cleared, ripoff, knockoff laser therapy caps on the market. We call them “zombies” because from a distance they look normal…but once you get closer, you see that their parts are falling off, they smell suspicious, and if you aren’t careful, they’ll hurt you.
Make no mistake: they’re out there, and they want your money. At a glance, they look no different from real products that get you real results. But those who buy them will tell you that opting to use one of these zombie products is the worst decision you can make with your hair.
The best-case scenario is that it doesn’t work. Worst case? The lasers and light wavelengths they use will damage your hair or scalp. Lasers must be finely calibrated and tested through every step of the manufacturing process. If they don’t constantly test the wavelength as demanded for FDA clearance, then the hair “growth” device might cause your hair to fall out faster.
Most good caps have been FDA-cleared to emit lasers at a wavelength of around 650nm. If you go too far below or above that 650nm, then you come into the territory of ultraviolet or infrared light. Prolonged, focused exposure to these wavelengths may cause your scalp to peel, your hair to fall out, and your skin to age. Not to mention the harm to your eyes and face.
Now before you start getting doubts about laser treatment therapy altogether, let’s be clear: the FDA approved devices work. The FDA spends a lot of time and money ensuring that they work, companies who invest in FDA clearance are reputable, up-front companies who believe in their product. The only exception we’ve seen to this are companies that pop up overnight with FDA clearance and haven’t had time to build the infrastructure to manage the quality control process needed for laser cap production. However…
Anyone selling without FDA approval is simply taking your money and putting your health at risk.
FDA Clearance Explained: Why It’s Important and How Some Companies are Trying to Scam You
Getting FDA clearance is a serious endeavor requiring a significant investment in time and money.
Some manufacturers attempt to skip this step for two reasons:
1) Their product doesn’t work, so they don’t want to bother getting rejected by the FDA
2) They’re just trying to capitalize on the latest trends. They know they won’t be around next year, so what’s the point in getting FDA cleared?
Without FDA regulation, neither the device itself nor its suppliers are held accountable to quality controls or manufacturing standards. Their products therefore tend to be unreliable, unsafe knockoffs. So, the manufacturers try to sell them for lower price points and make a profit before people find out.
It shouldn’t have to be said, but untested, uncleared medical products are extremely dangerous. Yet unsuspecting consumers are attracted by the better price, thinking that they’re getting a better deal.
But that’s not the case: in the best possible scenario, these uncleared products will simply not work, so you’ve wasted hundreds of dollars. In the worst case, these uncleared products will blast your scalp with unsafe infrared or ultraviolet light, damaging your skin and significantly speeding up hair loss. So, you’ve paid $300-$700 to have a machine make your hair fall out.
Think about it like this: if you’re sick, who would you trust? Your doctor or some unlicensed stranger selling uncleared pills from China?
Your safety and hair health are worth far more than you might “save” by using an uncleared alternative to FDA-cleared medical devices.
If you agree, keep reading. We’ve researched the top 4 companies selling non-FDA-cleared products and hoping to make a buck at your expense and exposed them in the ripoff report below.
This one of the worst offenders on the market. Hairguru is not at all FDA cleared, but they try to give the impression of being a reliable, upfront company.
They’ve invested in a professional website and investment in Google ads. The one thing they haven’t invested in? FDA clearance.
As we’ve seen, selling a non-FDA-cleared product means three things:
- They don’t care enough about you, your health, or the results from their product to invest the time and money in getting FDA clearance.
- Their product has not been rigorously tested by acceptable clinical standards and been found safe
- They cannot ensure compliance across all aspects of their manufacturing process
Even if they say that their caps emit light at a wavelength of 650nm, they’re lying by omission. They can’t know that for sure, because it has not been reliably tested. They’re attempting to sell you this product at a ridiculously high markup, so it will look just like a clinical, FDA-cleared product… but for all we know, you might be putting $800 into a cap that makes your hair fall out.
(And by the way, why do all the reviews on their website sound very similar… as if written using a template?)
This one’s almost as bad as Hairguru. If you type in “laser hair cap,”it’ll come up in Google. But just like the others on this list, it’s selling illegally – without FDA clearance. Just go over to the FDA website and type in ReHair, and you’ll get a “no results” page.
Anyway, ReHair promises to put out a 650nm laser wavelength at a pulse frequency of 4.5 hz. But there’s just no way of knowing if this is accurate. They could have simply copy-pasted that information from a reputable site.
Even with a website and the correct information, ReHair is a dangerous product – even more dangerous because it looks legitimate. It’s will probably continue to fool a few people into buying it. Don’t be one of them.
You can tell how reliable this company is by the fact that they don’t even have a website. They’re relying on you to stumble across them on Amazon, and they hope to lure you in with a low price.
So why is their price ludicrously low? Probably because they slash costs by skipping get FDA clearance and don’t care about providing a quality product.
Yet you can find them on Amazon, eBay, and even as affiliate ads on other sites. Be careful here. This $150 “laser helmet” might simply waste your money. Then again, it may damage your hair and scalp and cause hair loss. Is that a risk you’re willing to take?
Much the same as FunWill, you can find Yanuo products lurking around on Amazon. The Yanuo Laser Cap is another “zombie” without FDA clearance.
This one is blatantly dishonest. The amazon product description states that this laser helmet is FDA cleared and “clinical proven.” Pop over to the FDA website and search for “Yanuo,” and you’ll see that this is not the case. They’re just lying to you.
Furthermore, nowhere in the product description does it say what wavelength the lasers emit. It’s doubtful that the manufacturers even know, and much more likely that they’re simply trying to capitalize on a trend with lights that either do nothing, or make your hair fall out faster.
Bonus: Nameless eBay Zombies
These are too numerous to each get their own category. But if you search “Laser Cap” in ebay, these will pop up – unnamed, unbranded laser helmets designed to look like reputable helmets.
Far from being FDA-cleared, these helmets were assembled specifically to undercut medical helmets like Illumiflow and Theradome.
They sell for half as much as the usual price point – and you get even less than what you pay for. Even if the helmet turns on (doubtful), there’s no telling what type of light you’re subjecting your hair to or what kind of results to expect.
It really shouldn’t have to be said but getting your medical equipment from ebay is a risky idea at best. If you’re absolutely dead-set on doing so, just know that the only FDA-cleared sellers are Illumiflow, Grivamax, Capillus, Hairmax and iRestore. Everything else is a scam.
We’ll be updating this list with more products as they hit the market. “Zombies” are always popping up and fading away just as quickly. Although they might look legitimate at first glance, don’t waste your money or your time until you’ve confirmed they’re cleared by the FDA.
Illumiflow, Capillus, Hairmax and iRestore are the ONLY FDA-cleared laser caps on the market. They may cost slightly more, but that’s because they actually work and are safe to use. To spend money on other products is to put your investment and health at risk.