JUVÉDERM® Ultra XC – A filler approved by the U.S. FDA for certain facial wrinkles, folds, and lip volume enhancement

JUVÉDERM® Ultra XC is a dermal filler containing Hyaluronic Acid (HA) and the local anesthetic lidocaine, manufactured by Allergan. The product has been approved by the U.S. FDA for specific aesthetic medical indications on the face, including the lips, the area around the lips, and facial wrinkles. However, this does not mean the product is suitable for every patient or can be used freely on every area of the face. This article will help you gain a deeper understanding of this topic.

What is the FDA? 

FDA stands for the Food and Drug Administration, the U.S. government agency responsible for regulating medications, medical devices, and many other products related to public health.

In aesthetic dermatology, dermal fillers are classified as medical devices. They must undergo a rigorous evaluation process before they are allowed to be marketed in the United States. Before granting approval, the FDA carefully reviews the entire application and the scientific evidence submitted by the manufacturer.

The review process includes the product’s ingredients and characteristics, biocompatibility data, manufacturing process, quality control system, and clinical study data. The FDA also carefully evaluates the product’s safety and effectiveness for its intended indications, as well as its contraindications, potential risks, instructions for use, and labeling requirements.

It is important to note that not all dermal fillers on the market are approved by the U.S. Food and Drug Administration. A product is considered “FDA-approved” only for the specific indications that have been reviewed and included in its approval documentation. However, this does not mean the product is safe or effective for every injection site on the body.

Why does FDA approval matter? 

FDA approval indicates that a product has been evaluated for safety and effectiveness for the specific indications for which it was submitted. However, dermal fillers can still cause adverse effects or complications and may not be suitable for every patient. In addition to its rigorous pre-approval review, the FDA continues to monitor products after they enter the market.

To maintain approval, manufacturers must comply with a wide range of strict regulatory requirements. These include submitting periodic reports, continuously monitoring safety data, and reporting any serious adverse events. Manufacturing facilities must also comply with Unique Device Identification (UDI) requirements and maintain a robust quality management system. In addition, manufacturers must notify the FDA or obtain supplemental approval for any significant changes related to the product.

Furthermore, after a product has been approved, manufacturers may be required to conduct post-approval studies if requested by the FDA. They are also responsible for working with the FDA to issue safety warnings, implement corrective actions, or recall products if risks that could threaten patient health are identified.

These requirements demonstrate that FDA approval provides evidence of a product’s safety and effectiveness when it is used according to its approved indications. However, FDA approval does not mean the product is completely free of risks.

What indications is JUVÉDERM® Ultra XC approved by the FDA for? 

As mentioned above, JUVÉDERM® Ultra XC is an aesthetic gel dermal filler containing 24 mg/mL Hyaluronic Acid (HA) and 0.3% lidocaine. It is one of the flagship filler products manufactured by Allergan. Currently, JUVÉDERM® Ultra XC has been approved by the U.S. FDA for the following specific indications:

*Information is based on the U.S. FDA Premarket Approval (PMA) application P050047 and the FDA supplemental approval P050047/S005 and P050047/S044 for expanded indications.

Seoul Center Clinic chooses JUVÉDERM® Ultra XC – Prioritizing safety and transparency 

At Seoul Center Clinic, patient safety and well-being are the guiding principles behind every service we provide. That is why, when choosing JUVÉDERM® Ultra XC at Seoul Center Clinic, you can feel confident because:

• Seoul Center Clinic is committed to using genuine products with complete documentation verifying their origin and authenticity, giving patients peace of mind before undergoing treatment.
• The product is considered only for clinically appropriate treatment areas, in accordance with its approved indications, applicable local regulations, and the physician’s assessment.
• Patients are invited to personally inspect the product packaging, labels, and the sealed condition of the box before the physician begins the procedure.
• Most importantly, every treatment is performed after a thorough facial assessment by a qualified and experienced physician, who will recommend the most appropriate product, treatment area, and injection volume based on the patient’s facial anatomy and aesthetic goals.
• All filler procedures at Seoul Center Clinic are carried out in a controlled clinical environment that meets medical aseptic standards. The treatment area is appropriately cleansed and prepared, while sterile, single-use needles, syringes, and other applicable medical supplies are used in accordance with aseptic protocols.
• After the procedure, the physician provides detailed aftercare instructions and explains the signs patients should monitor during recovery. Our medical team follows up on the patient’s post-treatment response and recovery and provides further guidance when necessary.

These practices demonstrate that Seoul Center Clinic does not consider dermal fillers to be suitable for every patient. Each case is individually assessed by a qualified physician to determine the most appropriate product, dosage, and injection site. Therefore, you are encouraged to schedule a consultation at Seoul Center Clinic, where a physician can evaluate your condition and recommend the treatment that best suits your needs.

Frequently asked questions 

1. Is JUVÉDERM® Ultra XC FDA-approved? 

Yes. JUVÉDERM® Ultra XC has been approved by the U.S. FDA. In its official approval letter, the FDA confirmed that it had completed the review of the Premarket Approval (PMA) application and officially approved JUVÉDERM® Ultra XC for marketing.

2. What treatment areas is JUVÉDERM® Ultra XC FDA-approved for? 

As mentioned above, JUVÉDERM® Ultra XC is FDA-approved for the following indications:

• Facial folds and wrinkles: Injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds, such as the nasolabial folds.
• Lips and the perioral area: Injection into the lips and the area around the mouth for lip augmentation in adults 21 years of age and older.

3.Is JUVÉDERM® Ultra XC FDA-approved for lip augmentation in individuals 21 years of age or younger?

No. The FDA-approved indication for lip augmentation applies to adults over 21 years of age. Effectiveness for this indication was not studied in individuals under 22 years of age.

4. Do all JUVÉDERM® products have the same indications? 

No. Not all JUVÉDERM® products have the same indications. Each product in the JUVÉDERM® collection is formulated with different cross-linking technology, Hyaluronic Acid (HA) concentration, and gel consistency to optimize performance for specific facial treatment areas.

For this reason, a qualified physician should assess the degree of volume loss, wrinkle severity, and the intended treatment area—such as the cheeks, chin, lips, or jawline—to determine the most appropriate JUVÉDERM® product or combination of products for the best aesthetic outcome.

5. Are all dermal fillers on the market FDA-approved? 

No. Not all dermal fillers available on the market are approved by the U.S. FDA. The FDA grants approval to specific filler products after reviewing evidence supporting reasonable assurance of safety and effectiveness for their proposed indications.

6. Does FDA approval mean the product is risk-free? 

No. FDA approval does not mean a product is free of risks. Rare but serious complications may occur if filler is inadvertently injected into a blood vessel, including vascular occlusion, tissue necrosis, vision abnormalities, blindness, or stroke.

7. How long can lip augmentation results last? 

The results of lip augmentation with dermal fillers, particularly Hyaluronic Acid (HA) fillers such as JUVÉDERM®, are temporary. The duration of the results varies depending on individual factors, the treatment area, the amount of product used, the injection technique, and the body’s natural metabolism.

In the clinical study submitted to the FDA, 56% of participants continued to show improvement in lip fullness after one year. Whether additional treatment is needed should be determined through an evaluation by a qualified physician.

8. Who should not use this product? 

JUVÉDERM® Ultra XC is contraindicated in individuals with a history of severe allergies, anaphylaxis, or multiple severe allergies; those who are allergic to lidocaine; or those with an allergy to Gram-positive bacterial proteins used during the manufacturing process.

If the intended injection site has an active inflammation or infection, treatment should be postponed until the condition has completely resolved. Patients taking medications that may prolong bleeding, such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants, should inform their physician, as these medications may increase the risk of bruising or bleeding at the injection site.

The safety of JUVÉDERM® Ultra XC has not been established in pregnant or breastfeeding women or in individuals under 18 years of age. Therefore, all patients should undergo a medical evaluation by a qualified physician before considering treatment.

For more information or to schedule a consultation, please contact Seoul Center Clinic via the hotline 1800 3333 to receive professional support from our physicians.