This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Belotero Balance® (+)
PMA Applicant: Merz North America, Inc.
Address: 6501 Six Forks Road, Raleigh, NC 27615
Approval Date: September 27, 2023
Approval Letter: Approval Order

What is it?

Belotero Balance® (+) is a prescription gel implant or dermal filler that is injected to improve the appearance of depressed, sunken, or hollow areas under the eyes. The depression under the eyes is called infraorbital hollowing. Belotero Balance® (+) comes in a blister pack containing 1-mL of sterile gel prefilled in a glass syringe and packaged with two sterile needles and two patient record labels.

This approval expands the use of this product for infraorbital hollowing. It was previously approved for moderate to severe facial wrinkles and folds.

How does it work?

Belotero Balance® (+) is injected by a doctor into the skin under the eyes, between the lower eyelid and the cheekbone.

When is it used?

This new approval allows Belotero Balance® (+) to be used as a filler intended to improve infraorbital hollowing in people over the age of 21.

What will it accomplish?

Belotero Balance® (+) is intended to improve infraorbital hollowing. In a clinical study with 144 participants, people needed one or two treatments with multiple injections to achieve the best outcome. The results may last up to 48 weeks.

When should it not be used?

Belotero Balance® (+) is not for people who have:

• Anaphylaxis or multiple severe allergies
• Allergies to lidocaine or other amide-type anesthetics
• Allergies related to gram-positive bacterial proteins.

Additional information: (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data
• Labeling (Patient labeling)
• Labeling (Clinician labeling)
• PMA Database Entry
• FDA Dermal Fillers (Soft Tissue Fillers)