Skip links

Is AestheFill FDA approved?

When considering aesthetic treatments, safety and efficacy are paramount concerns for individuals seeking rejuvenation and enhancement. AestheFill, a cutting-edge biostimulator filler, has gained attention for its remarkable anti-aging benefits. But is AestheFill FDA approved?

Understanding FDA Approval

The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating medical devices, including aesthetic treatments like dermal fillers and injectables. FDA approval signifies that a product has undergone rigorous testing and evaluation to ensure its safety and efficacy for its intended use.

AestheFill and FDA Approval

As of today, AestheFill has not yet received FDA approval for use in the United States. However, the main ingredient in AestheFill, Poly-D-L-Lactic Acid (PDLLA), is FDA approved for certain medical applications. It’s essential to note that FDA approval is not a strict requirement for all aesthetic treatments. Many products and procedures are available to consumers through off-label use or under different regulatory pathways.

PDLLA: A FDA Approved Ingredient

PDLLA is a biodegradable synthetic polymer that has been FDA approved for use in various medical devices and treatments. PDLLA’s safety and biocompatibility profile have been well-established through extensive research and clinical studies, providing reassurance for its use in aesthetic procedures.

Off-Label Use

Off-label use refers to the practice of using a product for a purpose other than what it was initially approved for, under the discretion and expertise of a licensed medical professional. While AestheFill itself may not have FDA approval, PDLLA’s FDA-approved status allows qualified aesthetic doctors to use AestheFill off-label for cosmetic purposes. 

Consultation with a Qualified Aesthetic Doctor

If you’re considering AestheFill or any other aesthetic treatment, it’s crucial to consult with a qualified doctor who can assess your individual needs and provide personalized recommendations. A skilled doctor will prioritize your safety and well-being, guiding you through the decision-making process and ensuring that you receive the highest standard of care.

At GEM Aesthetic Clinic Malaysia, we have our experienced doctors available for consultation to guide you through our AestheFill treatment Malaysia and which procedures are the best suit for you. Don’t hesitate to book a consultation with us now!

What are the other Anti-Aging treatments we offer?

SculptraDermal Filler, ProfhiloThread Lift