FDA Approves Belotero Volume and Belotero Intense
The U.S. Food and Drug Administration (FDA) has approved two new hyaluronic acid fillers from Merz Aesthetics: Belotero Volume (+) is approved to improve volume deficit in the midface or correct midface contour deficiencies in adults age 22 and older, and Belotero Intense (+) is approved to temporarily add volume and improve lip fullness in adults older than 21.
The new products join Belotero Balance (+), which is already approved to correct moderate-to-severe facial wrinkles and folds and to improve infraorbital hollowing in adults over 21. Together, the expanded Belotero collection’s biomimetic hyaluronic acid (HA) filler portfolio addresses facial balancing, volume restoration, contouring and lip enhancement.
Belotero fillers are built on the company’s proprietary Cohesive Polydensified Matrix (CPM) gel technology, which is designed to support tissue integration and natural-looking outcomes while preserving facial movement and expression.
“The FDA approvals of BELOTERO VOLUME (+) and BELOTERO INTENSE (+) represent an important milestone for Merz Aesthetics in the U.S.,” says Patrick Urban, President of Merz Aesthetics North America, in a news release. “By expanding the BELOTERO portfolio and complementing our broader injectable offerings, we’re strengthening our ability to support healthcare professionals with a more comprehensive range of solutions, helping them meet diverse patient needs through a single trusted partner.”
Belotero Volume (+) is designed to restore volume and contour in the cheeks and midface, helping address age-related volume loss with natural-looking results that preserve facial expression. Through its CPM gel, Belotero Volume (+), creates smooth transitions between treated and untreated areas while delivering demonstrated results lasting up to 18 months.
Belotero Intense (+) is designed for lip augmentation, temporarily adding volume and improving lip fullness while supporting natural movement in one of the face’s most dynamic treatment areas.
“BELOTERO VOLUME (+) and BELOTERO INTENSE (+) are the culmination of years of research into how hyaluronic acid naturally behaves in skin,” added Samantha Kerr, PhD, Chief Scientific Officer at Merz Aesthetics, in the release. “Developed with biomimetic design principles, these treatments are engineered to work in harmony with tissue and support natural-looking outcomes across diverse patient needs. With these two products now available alongside BELOTERO BALANCE (+), providers have a unified portfolio they can confidently use across the full spectrum of aesthetic goals.”
“One of the greatest advantages of a broad hyaluronic acid portfolio is the ability to treat each patient with the right product for the right indication,” added Michelle Henry, MD, a dermatologist in New York City, in the release. “Whether treating the midface, lips or facial lines, the expanded BELOTERO portfolio allows providers to work with products designed around the same principles of tissue integration and natural movement. That consistency can help support treatment planning while delivering results that look and feel authentic to patients.”
Commercial availability is anticipated beginning October 14, 2026, for Belotero Volume (+) and December 1, 2026, for Belotero Intense (+).
View important safety information at www.BELOTERO.com.
