Is Revofil FDA Approved?

Last Updated On: March 25, 2025

Dermal fillers provide a non-surgical way to enhance facial features, restore volume, and smooth wrinkles. Experts predict that the global market may reach $12.2 billion by 2030, growing at an 8.7% annual rate. This growth is driven by the rising demand for minimally invasive treatments and advancements in filler technology. These injectables address signs of aging and volume loss, offering natural results, which makes dermal fillers a cornerstone in the pursuit of “ageless beauty” in modern aesthetic medicine.

Among the many filler brands available, Revofil has garnered attention for its innovative peptide technology, which enhances filler stability and longevity. Understanding the regulatory status of cosmetic products is crucial for ensuring patient safety and treatment efficacy.

This article will explore whether Revofil is FDA-approved, discuss its formulation, and provide insights into its safety and effectiveness for aesthetic treatments.

Key Takeaways

• Revofil fillers are not FDA-approved in the U.S., meaning they have not passed the FDA’s safety and efficacy evaluation.
• While unapproved in the U.S., Revofil has the CE Mark in Europe and has approval from South Korea’s Ministry of Food and Drug Safety, reflecting compliance with local standards but not equivalent to FDA approval.
• Using non-FDA-approved fillers like Revofil poses risks, including unverified safety and efficacy, legal liabilities for practitioners, and potential erosion of patient trust.
• Significant risks exist for healthcare providers who administer non-approved products, such as adverse reactions, increased malpractice claims, and penalties.
• Healthcare professionals should stay informed about regulatory statuses, prioritize FDA-approved treatments, and educate patients on the importance of FDA approvals to enhance transparency and trust.
• Practitioners operating internationally should confirm compliance with local regulations before using products like Revofil, even in regions where they have approval. 

About: Med Supply Solutions has been operating since 2016 and 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 if you want to buy Revofil Fillers online. 

REVOFIL AQUASHINE PTX

Hyaluronic acid

REJUVENATING COMPLEX (AMINO ACIDS, 12 VITAMINS, MINERALS, COENZYMES, 4 TYPES of PEPTIDES - Oligopeptide-34, Oligopeptide-51, Oligopeptide-72, Decapeptide-23)

$69.00

Tier pricing

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3 or more

$66.00 each

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$64.00 each

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REVOFIL® AQUASHINE SOFT FILLER

Hyaluronic acid

REJUVENATING COMPLEX (24 AMINO ACIDS, 14 VITAMINS, 8 MINERALS, A COENZYME, 4 TYPES of PEPTIDES - Oligopeptide-34, Oligopeptide-51, Oligopeptide-72 and Decapeptide-23)

$59.00

Tier pricing

Save 5.08%

3 or more

$56.00 each

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11 or more

$54.00 each

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REVOFIL AQUASHINE BR SOFT FILLER

Hyaluronic acid

REJUVENATING COMPLEX (24 AMINO ACIDS, 14 VITAMINS, 8 MINERALS, A COENZYME, 4 TYPES of PEPTIDES - Oligopeptide-34, Oligopeptide-51, Oligopeptide-72 and Decapeptide-23)

$59.00

Tier pricing

Save 5.08%

3 or more

$56.00 each

Save 8.47%

11 or more

$54.00 each

Save 10.17%

21 or more

$53.00 each

FDA Approval Status of Revofil

Currently, Revofil fillers are not FDA-approved for use in the United States. This means that the product has not gone through the FDA’s stringent evaluation process to verify its safety and effectiveness for U.S. patients. As a result, Revofil cannot be legally marketed or administered by healthcare providers within the U.S.

Regulatory Standards: FDA vs. International

Although Revofil does not have FDA approval, it has received certifications in other regions:

• Europe: Revofil has been awarded the CE Mark, signifying compliance with European health and safety standards.
• South Korea: Approved by the Korean Ministry of Food and Drug Safety (MFDS), indicating adherence to local regulatory guidelines.

However, it’s crucial to understand that these international certifications do not substitute for FDA approval, as each regulatory body has its own distinct process and criteria for evaluating medical products.

Clinical Implications of Using Non-FDA-Approved Fillers

Using non-FDA-approved fillers like Revofil in the U.S. comes with serious clinical implications:

• Safety and Efficacy: Without FDA approval, the safety and effectiveness of Revofil for U.S. patients haven’t been verified under U.S. regulatory standards, leaving some uncertainty about its true performance.
• Legal Restrictions: Administering non-FDA-approved fillers is illegal in the U.S., putting healthcare providers at risk of legal consequences.
• Patient Trust: Choosing unapproved products can damage patient trust and confidence in the provider, as patients may feel uncomfortable with treatments that haven’t been officially authorized.

Healthcare professionals should always prioritize patient safety by sticking to FDA-approved treatments.

Risks and Legal Considerations

Using non-FDA-approved fillers involves various risks and legal concerns:

• Adverse Reactions: Without thorough FDA-reviewed clinical data, there’s a higher chance of unexpected side effects or complications.
• Malpractice Claims: There’s an increased risk of legal action if complications arise from using unapproved products.
• Regulatory Penalties: Practitioners may face penalties, including fines or even losing their medical license, for violating FDA regulations.

To protect both patients and their practices, medical providers must adhere to FDA guidelines and use approved treatments.

Recommendations for Medical Providers

Staying up-to-date on the approval status of emerging fillers, like Revofil Ultra for lips, is crucial for responsible medical practice. Regularly reviewing updates from the FDA and other regulatory bodies allows healthcare providers to make well-informed, evidence-based decisions. This proactive approach not only protects patients but also shields practitioners from potential legal issues associated with using non-approved products.

Educating patients about the significance of FDA approval fosters transparency and trust. It’s important for patients to understand the risks of non-approved treatments and why opting for FDA-cleared products offers a higher level of safety. By maintaining open communication, providers help patients make informed decisions, reducing misunderstandings and improving treatment outcomes.

Conclusion

While Revofil offers innovative formulations and is approved in several international markets, it has not yet received FDA approval for use in the United States. Healthcare providers must follow FDA guidelines to ensure patient safety and uphold their professional integrity. 

Staying informed about the regulatory status of treatments and prioritizing FDA-approved options are critical steps in providing safe and effective care for patients.

FAQs

1. What is Revofil?

Revofil is a dermal filler that combines hyaluronic acid with biomimetic peptides. It can enhance facial volume and reduce wrinkles. 

2. Why does Revofil not have FDA approval?

Revofil has not undergone the FDA’s comprehensive evaluation process required for approval in the United States. ​

3. Can I use Revofil in countries outside the U.S.?

Yes, Revofil has approval in regions like Europe and Asia. However, practitioners should verify and comply with local regulations before use. ​

4. Are there FDA-approved alternatives to Revofil?

Several FDA-approved dermal fillers are available in the U.S., including Juvederm and Restylane.

References

Dermal fillers market size worth $12.2 billion by 2030. Grand View Research. https://www.grandviewresearch.com/press-release/global-dermal-fillers-market

Claysset B, Cavallini M. Combined protocol for restoration and repositioning of natural volumes of the face in a patient with peripheral hemiparesis of right facial side. Int J Clin Med Case Rep. 2022;18(1):003. doi:10.46998/IJCMCR.2021.18.000428