Are PDO Threads FDA Approved?

PDO threads are frequently used in aesthetic medicine procedures today to improve help people improve the look of their skin, particularly in the face. They’ve become so popular because the procedures are non-invasive, quick and painless, and require little recovery time

At the same time, PDO threads have proven to create amazing results, helping people achieve a fresher, more youthful look without the surgery that a traditional facelift requires.

With the procedures seemingly becoming more popular by the day, more and more providers are rushing to create PDO threads that can be used in these procedures. The question many patients who haven’t undergone one of these procedures before ask is whether PDO threads are FDA approved.

Below, we dive deeper into the topic of what PDO threads are and how the U.S. Food and Drug Administration treats them.

PDO threads are known as what is called FDA cleared. This is a designation that’s reserved for Class II medical devices. Only Class III medical devices can be fully FDA approved.

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Medically reviewed by: Elizabeth Williams RN
Updated: 7/12/2024

What Are PDO Threads?

PDO threads are thin hair-like threads that are inserted below your skin through the use of a pre-loaded cannula. There are many different types of PDO threads, including some that have barbs that grab onto skin and “lift” it up, mimicking the results of a traditional facelift.

One of the biggest benefits of PDO threads is that they are dissolvable by the body naturally. In fact, these dissolvable threads have been used in surgical procedures as sutures for decades.

This means that the PDO threads can be inserted and don’t ever have to be removed. The body will naturally break them down over time, without the need for any further action.

Another major benefit is the fact that, as the body works to break down the PDO threads, it increases the production of collagen in the region. The body produces the extra collagen to help break down the foreign object that it recognizes in the body.

In turn, the extra collagen that’s produced in the region helps to ensure that the results of the PDO threads procedure last even longer. It also gives your skin a glow that it may not have had before.

Learn more about how PDO Threads work here

How Does the FDA Handle Medical Devices?

One of the jobs of the FDA is to review all medical devices that manufacturers want to bring to the U.S. market. The agency does this in a similar way to how it approaches drugs. Before medical devices can be marketed to U.S. patients, it must be reviewed by the FDA.

There are three different classes for medical devices.¹

Class I is determined to be devices that carry a low risk. Some examples are manual wheelchairs and bandages.

Class II is determined to carry an intermediate risk. This could include CT scanners and infusion pumps that are used for IV medications.

Class III is determined to be devices that could carry a high risk, but are also extremely important to sustain life or health. Pacemakers are an example of a device that falls into this category.

What FDA Class Do PDO Threads Fall Under?

PDO threads are considered a Class II medical device. This means that the FDA has determined that there is an intermediate risk that the product presents.

This is mainly because PDO threads are a product that is inserted into the skin. Unlike, say, a bandage, the procedures should be done by a professional who is trained on how to handle the PDO threads and complete procedures with the product.

Since it is inserted under the skin, and not placed on top — again, like a bandage — there is naturally some risk of infection, swelling or other soreness. That is why the FDA has determined that PDO threads are a Class II medical device.

The classification in no way suggests that PDO threads are dangerous. It just signifies that patients should take special care when they are picking a practitioner to complete the PDO threads procedure, just as they would for other aesthetic medicine procedures such as dermal fillers.

So, Are PDO Threads FDA Approved?

PDO threads are known as what is called FDA cleared². This is a designation that’s reserved for Class II medical devices. Only Class III medical devices can be fully FDA approved.

Essentially, what this means is that the FDA has fully reviewed the product and determined that it’s substantially equivalent to another product that’s already on the market that’s been cleared or approved by the FDA.

After completing what’s called a 510(k) review process³, the FDA will determine that an FDA-cleared device can be brought to market and sold to patients in the U.S.

Visit a Practitioner That Uses Trusted PDO Threads

Unfortunately, there are some manufacturers of PDO threads that try to market their products to U.S. patients before they’re FDA cleared to do so. This step is crucial in ensuring that your procedure is done in a safe manner.

That’s why you should only trust medical practitioners that use PDO threads that are provided by V Soft Lift. For more information on our amazing suite of PDO threads, contact us today.

References

1. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
2. https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/
3. https://www.thefdagroup.com/blog/510k-explained