When it comes to laser cap devices like the Capillus, FDA approval and FDA clearance have different distinctions. In this article, we will break down the difference between FDA approval and FDA clearance. We’ll also explain how this relates to hair restoration devices such as the Capillus. As more health products enter the market, understanding the difference between FDA approval and FDA clearance is vital.

What’s the Difference Between Capillus FDA Approval vs FDA Cleared Laser Caps?

To begin with, the Food and Drug Administration is responsible for evaluating the safety and efficacy of many products. This includes prescription drugs for both humans and animals, over-the-counter drugs, vaccines, biotechnology products, and dietary supplements (though not all are subject to FDA regulation). They are responsible for regulating medical devices which include everything from a tongue depressor to a pacemaker, and surgical implants. The FDA also regulates food additives, cosmetics, products that give off radiation, tobacco, and infant formula.

So now let’s understand the meaning of “FDA approved” products. “FDA approved” means that the agency has determined that the “benefits of the products outweigh the known risks for the intended use”. In order to get this approval product manufacturers must submit the results of clinical tests as well as a premarket approval (PMA) application. How does the FDA make the determination that the benefits outweigh the risks?

The FDA is inclined to approve products that come with some risks if their potential benefits are more significant. A good example of this would be an artificial heart valve that has the potential to save someone’s life. Certain products need to meet FDA approval in order for those products to be marketed or sold in the US, especially if these products have a serious risk of injury or illness, while also having health benefits. Examples of this include prescription medications, over-the-counter medications, vaccines, and class III medical devices.

Medical Device Classifications 

The FDA categorizes medical devices into 3 types Class III, Class II, and Class I. Class III devices are defined as devices that are implanted in the body, are life-sustaining, or have the potential to cause significant injury or illness in the body. Examples of Class III devices include implanted pacemakers, replacement heart valves, and breast implants. Devices that are considered lower risk and products that are used outside the body such as condoms, motorized wheelchairs, or catheters fall into the Class II and Class I categories. For example, Apple’s ECG app for the Apple Watch is in Class II.

Class II and Class I medical devices are usually “cleared” by the FDA rather than “approved”. This includes Capillus. When a product is cleared this means that the manufacturer was able to demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has FDA clearance or approval. We call these predicate products.

A Hypothetical Example

Suppose Apple wanted to create a blood pressure monitor that used the same design and features of a blood pressure monitor that is already in existence. The FDA is likely to grant clearance if the company can demonstrate that its product is comparable to one that is already on the market, as well as demonstrate that their product is safe and effective, and works in the same way. In order for FDA clearance to be granted the company must submit a “premarket notification submission” or 510(k).

If the FDA determines that this medical device is substantially equivalent, the device is cleared and can be legally marketed and sold in the US. Some may argue that this creates ongoing problems for ensuring that consumers have access to safe products and devices because they are getting cleared based on older predicates that are actually unsafe. And that’s not untrue. Some people take advantage of the system. They use this as a loophole. Keep in mind that most Class II and Class I devices are non-invasive and have already been determined unlikely to cause bodily harm.

Capillus FDA Approval Has Not Yet Occured

So now that we’ve managed to distinguish the differences between FDA Approval vs clearance we can begin to explore the difference between Capillus FDA approval and FDA-cleared hair devices. Because laser caps are noninvasive and low-level laser therapy (LLLT) has no known side effects, it would not qualify as a class III device. For this reason, it is not necessary for it to be “approved” by the FDA. However, it’s important to know that. There is a difference. And it doesn’t necessarily mean anything negative or positive. That all depends on the manufacturer and how reputable they are.

Capillus Has A Solid Reputation

Capillus, LLC is a medical device manufacturer. They develop products designed to address hair loss through the use of low-level laser therapy. Capillus received FDA clearance for use as in-home laser therapy for the treatment of hair loss. This hair restoration company manufactures products that can be purchased over the counter. However, some are not available in stores. Some devices like the Capillus RX 312 are only available through partnering physicians and hair clinics. 

Capillus laser caps use low-level laser diodes to stimulate blood flow to the scalp and hair follicles. This encourages increased growth as well as improving hair health. The caps are lightweight and made from flexible hypoallergenic materials that mold to the shape of your head. Treatments only require 6 minutes of use per day.

A Capillus trial showed success in more than 95 percent of active clinical study participants. Participants showed an average of 51 percent more hair within 16 weeks. You can view the full study at www.clinicaltrials.gov. The reason the CapillusRX 312 is so effective is because of its high concentration of prescription-strength laser diodes. With 312 laser diodes, this laser cap provides generous scalp coverage, increasing circulation to the scalp and hair follicles.

Not All Hair Restoration Hats Work Well

Be mindful that not all laser caps have been cleared by the FDA. Especially cheap imported knock-off devices! Steer clear of these products if you want to avoid wasting money. They’re prone to break, lose parts, smell bad, and in extreme cases even cause harm to you and your hair. For instance, laser caps that have been FDA-cleared have been tested at several stages of their manufacturing process. This is to ensure that the lasers are emitting a safe wavelength of around 650nm.

If the laser diodes have not been constantly tested to make sure they are emitting the proper wavelengths, the laser cap could fail to be effective. If the device emits wavelengths too far above or below the 650nm required for FDA clearance, expect unfortunate unintended consequences. A non-FDA cleared laser device could cause problems such as irritation or peeling on the surface of the scalp. Additionally, it may accelerate aging of the skin, and increased hair shedding. 

Remember that FDA clearance is a sign that the company manufacturing the product cares about the consumer experience. It matters to them that they are producing high-quality products that will not be harmful to their customers. You may find low-cost products that are not FDA-cleared on websites such as eBay, Amazon, and Wish. You may find others that are. And let’s be honest. Some manufacturers use loopholes to sell garbage products.

If you don’t see FDA clearance on your laser cap device it is not worth any short-term savings. The best case scenario is that you will see no changes whatsoever. Worst-case scenario, you may find yourself having to undo even greater amounts of damage to your hair and skin. Needless to say, and short-term savings is not worth any long-term consequences.

Stay Vigilant 

A big red flag that you are dealing with a dangerous generic laser device with no FDA clearance is if the product comes with shady disclaimers, like this:  “FDA Disclaimer Statement: The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping the item.”  Translation: “we did not go to the trouble of getting this cleared by the FDA, so there’s a chance we won’t be able to legally sell you this product.” Yikes, am I right?

If you see a disclaimer like this on a laser cap product, RUN. The manufacturers of this product are unscrupulous, riding trends, and have no consideration for the customers who they are scamming and potentially harming. A lot of these imitation products won’t last on the market very long before their manufacturers go out of business. Especially those promising more than they can deliver.

In the End, Capillus is Still a Wise Choice

While you may experience a little bit of sticker shock when looking at the prices of quality laser cap devices like the CapillusRX 312, keep in mind that you get what you pay for. It’s better to save up for a device that will actually restore your hair. One with a solid reputation and warranty. LaserCapMe offers the best prices anywhere on the CapillusRX 312. By participating in their Before and After photo study our clients are eligible for an additional $1000 rebate. This offers significant savings. All our clients need to do is document their progress and hair growth by taking regular well-lit photos.

Now that we’ve looked deeper at Capillus FDA approval vs FDA cleared hair devices we have a better understanding of why FDA clearance is so important for laser hair therapy devices. However, you should now understand that some companies may use this to their advantage as well. After all, hair loss can be a very painful experience. Many people experience confusion and frustration over the multitude of products and supposed cures on the market.

It can be hard to trust that making such a big purchase, such as the CapillusRX 312 will actually be worth the expense. Do your research, look at before and after photos, and feel free to contact our team with any questions. While it does require patience and consistency CapillusRX 312 can make a real difference.

Call Us for Your Capillus Lasercap

Why wait? Contact us today to ask about the Capillus 312 laser device. Laser Cap Me offers better prices for the Capillus hair cap laser hair restoration hat than you can find for a lesser-grade device. So what are you waiting for? Stop hair loss now! Contact us or visit our store to purchase your Capillus 312.

You can reach us at 213-403-0455, or send us an email. You can also find out further details by visiting our clinic’s site Best Hair Transplant.