Aqualyx FDA Approval Status​

Last Updated On: April 24, 2025

Injection lipolysis has gained popularity as a non-surgical method for reducing localized fat deposits. Systematic reviews and clinical studies have shown that treatments using phosphatidylcholine and deoxycholate compounds, such as Aqualyx, can effectively target areas like the face, upper arms, and thighs. Most patients experience noticeable improvement after a series of sessions.

Aqualyx is an injectable fat-dissolving product that utilizes deoxycholic acid derivatives to break down fat cells. While it is approved for use in several European countries, the U.S. Food and Drug Administration (FDA) has not approved Aqualyx. They have issued warnings regarding the potential safety risks of unregulated fat-dissolving injections.

In this article, we will explore Aqualyx’s FDA approval status. We will discuss its clinical applications, and highlight key considerations for those contemplating its use.

Key Takeaways

• Aqualyx is not FDA-approved in the United States. This means it cannot be legally used for clinical fat reduction treatments within the U.S.
• In contrast, Aqualyx holds CE marking in Europe, which allows its use for non-surgical body contouring in countries such as the UK, Germany, and Italy.
• U.S. practitioners are limited to FDA-approved alternatives like Kybella, CoolSculpting, and SculpSure for localized fat reduction.
• Legal use of Aqualyx in the U.S. is prohibited, and the FDA has issued warnings about unregulated fat-dissolving injections.
• Patients and providers alike must verify product authenticity, adhere to local regulations, and seek treatment only from certified medical professionals.

About: Operating since 2016, Med Supply Solutions is known for being one of the industry’s top and trusted suppliers of cosmetic and viscosupplementation products. Contact our sales department for more information about buying Aqualyx online.

Current Regulatory Status in the U.S. and Europe

Aqualyx has not received FDA approval in the United States. This means it is not legally available for aesthetic or medical use within the country. The FDA has not reviewed its safety, effectiveness, or manufacturing standards. As a result, its use in clinical practice is a potential regulatory violation. U.S. practitioners are strictly limited to using alternative fat-dissolving injectables that have received formal FDA clearance.

In contrast, Aqualyx holds CE marking in Europe. This indicates that it complies with the European Union’s health, safety, and environmental standards. Many aesthetic clinics across the UK, Germany, Italy, and other European countries use Aqualyx for their patients. Their use involves treating localized fat pockets in areas such as the chin, thighs, and abdomen. 

Its broad approval and widespread use in these regions make it a preferred non-surgical body contouring option in Europe.

Implications for Clinical Practice

In the U.S., the absence of FDA approval limits the use of Aqualyx strictly to research settings or prohibits it entirely in commercial practice. Instead, U.S. providers often rely on FDA-approved injectables such as Kybella, particularly for submental fat reduction.

In European countries where Aqualyx is authorized, clinicians must undergo specialized training. This helps them master the intralipotherapy technique, which is essential for effective outcomes and patient safety. Mastery of Aqualyx dosage is also critical. Administering the correct amount based on body area, fat volume, and tissue sensitivity ensures the desired aesthetic result while minimizing complications.

Legal Considerations and Compliance

The unauthorized use of unapproved fat-dissolving injections like Aqualyx in the United States can lead to legal penalties and significant health risks. The FDA has publicly warned against “lipo injections” marketed online or administered in unlicensed med-spas. Some reports link these to adverse reactions, infections, and tissue damage.

Healthcare providers must be vigilant in maintaining compliance with regional regulations. They should use only approved therapies, and verify that all injectables come from licensed, reputable distributors. This safeguards both the patient’s well-being and a provider’s legal standing.

Alternatives with FDA Approval

For those practicing in the U.S., Kybella remains the only FDA-approved injectable for the reduction of submental fat. Its active ingredient, deoxycholic acid, breaks down fat cells in the targeted area. Multiple clinical studies support its safety and efficacy.

Other non-injectable, FDA-approved fat reduction technologies include CoolSculpting. This method uses cryolipolysis (controlled cooling) to freeze and eliminate fat cells. Additionally, there is SculpSure, which relies on laser energy to target stubborn fat deposits. These alternatives offer safe, non-surgical options for patients seeking contouring solutions without downtime.

Conclusion

While clinicians widely use Aqualyx across Europe for non-surgical fat reduction, the FDA’s lack of approval in the United States limits its availability and use. Practitioners must stay informed about regional regulatory guidelines. They should ensure they offer safe, evidence-based treatments within the legal framework of their country.

For those considering Aqualyx in approved regions, understanding Aqualyx dosage protocols and proper injection techniques is key to achieving safe, predictable results. With growing demand for non-invasive fat reduction, adherence to clinical best practices and legal compliance is more important than ever in the field of aesthetic medicine.

FAQs

1. Does Aqualyx have FDA approval in the United States?

No, Aqualyx does not have FDA approval and is not legally available for clinical use in the United States. The FDA has not evaluated its safety or efficacy. They have also issued warnings about vendors selling unapproved fat-dissolving injections like Aqualyx online or facilities using them without licenses.

2. What is the active ingredient in Aqualyx?

Aqualyx contains a modified compound of deoxycholic acid. This bile acid derivative helps break down fat cells by disrupting their membranes. This allows the body to metabolize and eliminate the fat naturally.

3. Are there alternatives to Aqualyx that have FDA approval?

Yes. Kybella is the only FDA-approved injectable treatment for reducing submental (chin) fat in the U.S. Other FDA-cleared non-surgical fat reduction options include CoolSculpting (cryolipolysis) and SculpSure (laser fat reduction).

4. Can practitioners in the U.S. use Aqualyx off-label?

No. Since Aqualyx lacks FDA approval, regulatory bodies prohibit its use in the United States. Using unapproved fat-dissolving injections can pose serious health risks and legal consequences. Patients and practitioners should only use FDA-approved treatments to ensure safety and compliance.

5. What areas can Aqualyx treat?

Clinicians commonly use Aqualyx in Europe to target localized fat deposits in areas such as the chin (double chin), abdomen, flanks (love handles), thighs, upper arms, and back. It does not deliver overall weight loss but is effective for contouring stubborn fat pockets.

References

Shaikh J. How effective are Fat-Dissolving injections? 4 steps, side effects. MedicineNet. Published May 5, 2022. https://www.medicinenet.com/how_effective_are_fat-dissolving_injections/article.htm

Patel R. About Aqualyx Fat-Dissolving Injections. Healthline. Published December 12, 2020. https://www.healthline.com/health/aqualyx