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Does FDA Approval Really Matter?

Does FDA Approval Really Matter?

What to Know About FDA Approved Hair Removal Devices

With all the different hair removal options available to you, from shaving to epilators, waxing to lasers, how can you be sure that the method you choose and the products used to perform the treatment are safe and effective? Well, one important distinction that should not be overlooked is clearance by health and safety organizations such as the Food and Drug Administration (FDA).

You’ll see terms like ‘FDA approved’ or ‘FDA cleared’ being used in marketing material and on physical product labels for all types of products, not just hair removal devices, especially those that have some type of medical, health, or aesthetic function. However, have you ever wondered what it actually means, and what the process is for a product to earn this designation?

When it comes to hair removal devices, it’s extremely important that they pass certain standards and conform to the necessary regulations set forth by organizations like the FDA to ensure your safety. In this article, we’re going to break down what these organizations do, what the different terms really mean, how they apply to hair removal devices.

What do organizations like the FDA really do?

First, it’s important to understand the role that these organizations play in ensuring the safety of the people purchasing and using these types of products. The FDA and oversees the regulation of an extremely broad range of products, chemicals, food additives, and technologies. For example, new drugs, medical devices, food colors and biologics all must be cleared and approved by the FDA before they can be made available for sale.

In addition, these governing bodies don’t only oversee the products themselves, but also the manufacturing processes and facilities. This is necessary to ensure quality control and safety measures intended to prevent contamination, tampering, and other issues that can pose risks to the general public.

When it comes to medical devices, which in itself is quite a broad category, the FDA reviews each device according to a risk-based, tiered methodology that categorizes each device in to one of three classes.

  • Class 3 devices are those that are considered the highest risk, and include things like pacemakers, implantable pumps and valves, such as artificial heart valves.
  • Class 2 devices are considered to be of moderate risk level for the user, and include things like dialysis machines, catheters, and electric wheelchairs. Hair removal devices that use intense pulsed light technology are generally considered to be class 2 devices.
  • Class 1 devices are considered the lowest risk to the user for potential harm and include a vast array of consumer products such as bandages, breast pumps, and various types of medical exam supplies like gloves and tongue depressors.

With hair removal devices falling into the class 2 category, you can see why it would be very important to ensure that they meet all the necessary safety standards. However, there are multiple ways that you may see this information phrased on manufacturers websites and on the product packaging.

What’s the difference between ‘FDA approved’ and ‘FDA cleared’?

Most often, the FDA provides what is known as a ‘cleared’ status to class 2 devices, while class 3 devices undergo more extensive regulation and would be labeled as ‘approved’. In most cases, the FDA applies a cleared-designation to class 2 devices once it is shown that they are substantially equivalent to a legally marketed predicate device.

In other words, ‘approved’ is generally reserved for higher-risk medical devices, whereas ‘cleared’ is used more commonly on consumer products of a medical or aesthetic nature. In addition, manufacturers who are developing a product that they believe to be similar enough in technology and function to an existing device, they can file for an exemption known as a 510(k) through the FDA. The FDA will then review the filing and determine its validity.

What does FDA clearance mean for hair removal devices?

For hair removal devices, FDA clearance provides a certain level of assurance to the consumer that their device has been reviewed and deemed as safe for use. Since hair removal devices come in direct contact with the skin, it is absolutely critical that the technology used in their design will not harm or injure the user. This includes factors such as the power of the device and the nature of the hair removal approach, as well as aspects such as the physical construction of the product.

If a hair removal device does not clearly and specifically state that it is cleared or approved by the FDA, it would be wise to steer clear of that device in favor of an alternative that has passed under the necessary scrutiny to ensure safety and effectiveness. Fortunately, with Silk’n IPL hair removal devices, you can count on each and every model being FDA cleared.

In fact, we’re extremely proud that Silk’n was the first company to obtain FDA clearance for at-home intense pulsed light hair removal devices in 2008. Since then, Silk’n designers have continually worked at improving and refining these technologies to deliver even better results, right in the comfort of your own home with no costly laser treatments or time-consuming clinic appointments.

How are Silk’n FDA-cleared hair removal devices different from others?

The biggest difference between Silk’n IPL hair removal devices and others that are on the market is in the combination of technologies and features that Silk’n offers. For example, the Silk’n Infinity is a unique device that combines the proven effectiveness of intense pulsed light hair removal with the added benefits of galvanic energy. This galvanic energy is produced by an electrode on the tip of the device, which helps to stimulate the treated area of skin and helps to open up the pores of the skin.

This added stimulation of the skin and opening of the pores allows the pulses of light to penetrate deeper into the follicle down to the root, providing more effective and longer lasting hair removal results in less time and with fewer treatments. In addition, the Silk’n Infinity also has a super-long-life emitter bulb that lasts for up to 400,000 pulses of light, which is enough for a lifetime of hair removal treatments.

What about other certifications or approval stamps?

Of course, the FDA is not the only regulatory agency in the world. Because of this, you may find some products on the global market that carry other types of approvals and clearances. However, you must keep in mind that there’s no guarantee the testing processes used by these other agencies will be the same or equivalent to those used by the FDA or Health Canada.

It is for this reason that we strongly recommend that you look for products that specifically carry FDA and/or Health Canada clearance markings depending on where you’re purchasing the device. This is the only way to be certain that they’ve passed the thorough and rigorous testing procedures that are necessary to earn those marks and assure safety for users.

Safely and Effectively Achieve Long Lasting Hair Removal with Silk’n

Now that you know what it really means for a product to be FDA cleared, we hope that it has helped to clear the air on which hair removal devices are truly leading the way in terms of quality, effectiveness, and innovation.

When it comes to your safety, you deserve only the best protection, and at Silk’n we make sure our technology is thoroughly tested and rigorously reviewed to provide only the best results.

Choose the Silk’n Infinity today, and experience how easy it is to quickly and safely get permanently smooth, hair-free skin!

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