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Is Ulike Hair Removal Device FDA Approved or FDA Cleared?

September 20, 2023
7 minutes
Is Ulike Hair Removal Device FDA Cleared

Nothing matters more than your health and you cannot risk damaging your skin for minor procedures like hair removal. You can find IPL hair removal devices from different well-known brands or small businesses but is every IPL device safe?

The devices that are either FDA-approved or FDA-cleared are safer and more effective as they are properly backed up by the FDA for their safety.

One of such top brands of IPL hair removal devices is the Ulike Hair Removal Handset. But is it recognized by the FDA? Let’s discuss.

Table of Contents:

What is the FDA and What Do They Do?

What is the FDA and What Do They DoThe Food and Drug Administration is the federal government agency in the U.S. responsible for ensuring the health of the public. They work to keep the public safe by making sure that the food, medicines, electrical devices, and various other products that we use in our daily lives are safe, effective, and made under sanitary conditions.

The drug administration is responsible for reviewing the laboratory results and monitoring the products for their efficacy before they are sold in the market. They check the production, benefits, and associated risks of all the products before approval. In short, it is a U.S.-based administration responsible for allowing only those products in the market that are manufactured safely, follow safety laws, and are not detrimental to human health.

Why Should You Buy FDA-approved IPL Devices?

What is Meant by FDA-ApprovedFDA-approved or FDA-cleared IPL devices indicate that they have undergone all the necessary results that prove their safety. Approval from the FDA shows the reliability and effectiveness of the device. Hence, using FDA-approved devices minimizes the risk of skin damage, burns, and other side effects of hair removal.

On the other hand, if you are buying non-FDA-approved devices, it means you are inviting danger to your house. These products have no proof that they are safe except the company claims. It is like taking a risk to use these devices. So, make sure you are buying FDA-approved products so that you can stay safe and enjoy the benefits of the product you spend money on.

What is Meant by FDA-Approved?

FDA-approved means the particular product is reviewed by the CDER and its benefits and side effects are weighed with the targeted community in mind. If the Benefits outnumber the side effects, FDA approves this product to sell in the market.

They take into account all the information regarding the risks and advantages of the product along with all the possible uncertainties that might occur due to incomplete data submission. Then, risk management strategies are applied and FDA-approved products are labeled with all the possible risks and side effects of that product.

What is Meant by FDA-Cleared?

What is Meant by FDA-ClearedSome products have FDA-cleared labels on them and we often assume that as FDA-APPROVED but it is wrong. FDA-cleared and FDA-approved are two different terms and cannot be confused. We will learn what FDA-cleared is in this section.

An FDA-cleared product is one in which the manufacturing company shows that their device is substantially equal to another similar product that is already sold in the market and is cleared by the FDA. The already-cleared devices that manufacturers use as a reference is called a predicate.

For FDA clearance on a product, companies submit a 510(k) submission or a premarket notification submission so that the product comes into the knowledge of the FDA and they can approve it.

What is the Difference Between FDA Approved and FDA-Cleared?

Now you have a little know-how on what is FDA-cleared and FDA-approved and how buying an FDA-approved or cleared product can save you from many side effects of IPL devices. But, If all the devices reviewed by FDA are safe then why can we not use the same term for all?

There is a difference between FDA-cleared and FDA-approved products

FDA approval is required for devices that can pose the highest threat to human life. These devices belong to the class 3 category of FDA classes. On the other hand, FDA clearance is required for those devices that come under classes 1 and 2 and are not highly dangerous for humans to use.

For FDA clearance, the company only needs to prove that its product is as good as the predicate while for FDA approval, FDA reviews proper clinical trials.

What Are the Three FDA Classes of Medical Devices?

FDA has divided medical devices into three different glasses based on their potential risks.

Class I: This category involves the device with minimum risk of causing any damage to human health. 47% of all the medical devices in the U.S. come under this division and 95% of these devices are exempt from any regulatory process. This implies that most products that come under this category do not need any premarket process.

Class II: These are devices that pose a medium risk to human health and 43% of devices come under this category. Some of the devices under this category need to submit a premarket notification of 510(k) to get approval from the FDA.

Class III: This category involves all those devices with maximum risk for human health. About 10% of devices are placed in this class. These products require a thorough review from the FDA before being sold into the market. For example, pacemakers are devices that can control a person’s heartbeat and come under class III.

Is Ulike  Hair Removal Device FDA-Approved or FDA-cleared?

Is Ulike Hair Removal Device FDA-ApprovedThe Ulike Hair removal device is FDA-cleared. It has obtained clearance from the Food and Drug Administration of the U.S. It is gentle on your skin and the intense pulsating light is not strong enough to burn your skin as long as you are using it the right way.

What Do Dermatologists Have to Say About Ulike?

The Ulike hair removal device is not only FDA-approved but various board-certified dermatologists have also personally tested it and recommended it to those who want a permanent solution to hair removal. </a >

Is Ulike IPL Hair Removal Device Clinically Tested?

Is Ulike IPL Hair Removal Device Clinically TestedThe Ulike IPL hair removal device is also clinically tested and has gotten certifications from not only the FDA and is recommended by dermatologists but also clinically tested for its safety and effectiveness.

It has gotten certifications from various other health organizations all around the world. These certifications include those from Japan Product Safety Certification, Korean Ministry of Food and Drug Safety Certification, UK Product Safety Certification, and Canada Product Safety Certification.

What Are the Benefits of Using Ulike Hair Removal Device?

Ulike Sapphire Air 3 handsetAll the Ulike devices can provide good results for hair removal. Our most recent release is the Ulike Sapphire Air3 handset which is slim with a pretty and user-friendly design. The small handset fits perfectly in your palm. It is cleared by the FDA and shows effective results within a few uses. Let’s see how this device is distinct from others.

Works Quickly

The Ulike Sapphire Air3 IPL hair removal device works as quickly as 7 minutes to remove your body hair. It has an auto-glide mode for your whole body to quickly glide the device on your whole body.

Moroever, you will start seeing the results just within 3 weeks of use and can get a complete hair removal in less than 4 months.


IPL hair removal is not completely painless but the effect can decrease as some devices come with cooling technologies. Similarly, the Ulike Sapphire Air3 handset has a 4-fold-ice cooling technology that gives your body a soothing and calm sensation.

It also prevents your body from overheating as the cooling system keeps the temperature within the range and gives 30 minutes of cool feeling at 50°F


The device costs $329 and is incorporated with an unlimited number of flashes so that it can work for a long time even 10 years or more. Unlike Ulike, shaving can cost more than $10,000 while waxing can cost more than $20,000 for a lifetime.

This shows how economical Ulike is for it’s users. It costs less than 10 percent of shaving or waxing for your lifetime.


The Ulike handset is diverse. Why? Because you can use it in all areas of your body. A single device can treat every area so what can be a better package than this?

It has three modes. The soft modes for sensitive areas like lips, face, and bikini line. The power mode is for areas like armpits and chest while the body mode is for large areas like arms and legs.

To learn more about the Ulike Sapphire Air3 Handset, Click Ulike IPL Hair Removal.


FDA-clearance or FDA approval ensures the safety of a device and the Ulike Hair Removal Device is FDA-cleared, dermatologist-recommended, and certified by various administrative organizations all around the world. It is user-friendly, quick, safe, and durable. So you can trust the handset and get yourself ready for a perfect hair removal session with Ulike.

If you have any further queries regarding IPL, click Common Question About IPL Hair Removal.

Welcome to Ulike! We hope our expertise can bring value to you.
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