Hyafilia
Published by Andrea Stearns
Last Updated On January 15, 2025

Is Hyafilia FDA Approved? – A Look at Its Approval Status

Jan 8, 2025

Studies and experts underscore the significance of using FDA-approved cosmetic non-invasive products. These products undergo rigorous testing to ensure safety and efficacy, reducing the risk of adverse reactions and complications.

Hyafilia is a widely-used dermal filler that has recently gained attention as it awaits potential FDA approval. Designed to address various aesthetic concerns, such as restoring volume and reducing wrinkles, its regulatory status remains under review.

In this article, we will explore Hyafilia, including its FDA approval status and feedback from both patients and practitioners, to help you understand its benefits and effectiveness.

Key Takeaways

• Hyafilia is not yet FDA-approved in the U.S. but is available in several other countries, pending further approval.
• Hyafilia addresses wrinkles, facial volume loss, and nasolabial folds and enhances facial contours, including cheeks and lips.
• Made from hyaluronic acid, a naturally occurring substance, Hyafilia restores skin hydration, plumps the skin, and smooths wrinkles.
• Common side effects include mild swelling, bruising, or redness. These are temporary and generally resolve within a few days of treatment.
• Hyafilia’s effects typically last between 6 to 12 months, with individual results varying depending on the treatment area and lifestyle factors.

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What is Hyafilia Filler?

Hyafilia is a hyaluronic acid-based dermal filler designed for facial aesthetics. Hyaluronic acid is a naturally occurring substance in the skin that helps maintain hydration and volume. It is commonly injected to reduce wrinkles, restore volume, and enhance facial contours. The results are smooth and natural-looking, lasting 6 to 18 months, depending on the treatment area.

Known for its high safety profile, Hyafilia requires minimal downtime, making it a popular choice for non-surgical facial rejuvenation. Its ability to provide effective and lasting results with minimal recovery time contributes to its growing popularity in aesthetic medicine.

FDA Approval Process for Hyafilia Filler

The FDA approval process for medical devices like Hyafilia filler is stringent and designed to ensure safety and effectiveness. This comprehensive process involves multiple steps and rigorous evaluations to bring a safe and effective product to market. Its key steps include:

• Device Classification: Determine the device’s classification (Class I, II, or III) based on the risk it poses and the regulatory controls needed to ensure its safety and effectiveness.
• Premarket Notification (510(k)) or Premarket Approval (PMA): Depending on the classification, submit either a 510(k) or PMA application. Hyafilia filler, being a dermal filler, typically requires a PMA.
• Clinical Studies: Conduct controlled clinical studies to gather evidence of the product’s safety and effectiveness.
• Review and Inspection: The FDA reviews the submitted data and may inspect the manufacturing facility to ensure compliance with regulatory standards.
• Approval or Clearance: If the product meets all FDA requirements, it receives approval (PMA) or clearance (510(k)) to be marketed.

The FDA approval process for Hyafilia filler involves thorough and detailed steps to ensure the product is safe and effective for its intended use. This process helps maintain high standards in the medical device industry, ensuring positive Hyafilia patient reviews for safety and efficacy.

Implications of FDA Approval

FDA approval of Hyafilia filler represents a significant milestone, confirming its safety, efficacy, and quality for medical aesthetics. This approval ensures the product meets rigorous standards by U.S. regulatory authorities, giving practitioners and patients confidence in its use. It allows Hyafilia to be marketed and used widely in the U.S. for facial rejuvenation treatments.

Implications of FDA Approval:

• Credibility and Trust: Enhances the trust of practitioners and patients in the product’s safety.
• Regulated Option: Assures patients of a well-regulated and reliable filler.
• Increased Availability: Opens up broader access to the U.S. market.
• Peace of Mind: Provides reassurance to patients about the product’s development and regulatory oversight.

With this approval, Hyafilia is poised to become a trusted choice in the competitive hyaluronic acid-based dermal fillers market.

Global Approval Status of Hyafilia Filler

The global approval status of Hyafilia filler varies by region. In the United States, Hyafilia fillers are not FDA-approved, meaning they are considered off-label. However, they are widely used in other markets where regulatory standards differ. 

• China: Approved by the National Medical Products Administration (NMPA) in September 2024 after successful clinical trials.
• Europe: Widely introduced across numerous countries, gaining acceptance and usage for various aesthetic procedures.
• Middle East: Gaining popularity and receiving regulatory acceptance in several countries for aesthetic and medical use.
• Thailand: Available for aesthetic use, approved by local health authorities, and widely marketed for treatments.
• Brazil: Approved and marketed for use, following regulatory clearance and gaining popularity in aesthetic practices.

Practitioners and patients must know their region’s regulatory status and consult with qualified professionals to ensure safe and effective use.

Conclusion

Hyafilia filler isn’t officially FDA-approved in the U.S. yet, so doctors must inform patients. However, it has received CE certification in Europe, confirming it meets safety standards. Approval status varies by country, so it’s essential to understand the regulations in your location before considering or offering this treatment. Always consult a professional to ensure you’re fully informed.

FAQs

1. What is Hyafilia filler? 

Hyafilia is a hyaluronic acid-based dermal filler to restore volume, reduce wrinkles, and enhance facial contours.

2. Is Hyafilia FDA-approved? 

Hyafilia is not FDA-approved in the U.S., but it has received CE certification in Europe.

3. What areas of the face can Hyafilia treat? 

Hyafilia is commonly used for treating wrinkles, nasolabial folds, cheek volume loss, under-eye hollows, and lip enhancement.

4. Is the procedure painful? 

Most patients experience minimal discomfort. Hyafilia contains lidocaine, a numbing agent, to reduce pain during injections.

References

The Importance of Using Good Quality, FDA-Approved, and CE-Marked Products in Aesthetic Medicine | Dr Michelle Westcott Aesthetic Academy. Aesthetic training.ie. Published 2025. Accessed January 9, 2025. https://www.aesthetictraining.ie/the-importance-of-using-good-quality-fda-approved-and-ce-marked-products-in-aesthetic-medicine/ 

Adam A, Karypidis D, Ghanem A. Thread Lifts: A Critical Analysis of Treatment Modalities. Journal of Drugs in Dermatology. 2020;19(4):413-417. doi:https://doi.org/10.36849/jdd.2020.3646 

Gold M. Use of hyaluronic acid fillers for the treatment of the aging face. Clinical Interventions in Aging. 2007;Volume 2:369-376. doi:https://doi.org/10.2147/cia.s1244