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Belotero® Balance

Price range: $189.00 through $209.00

BELOTERO BALANCE 1×1.0ml is used to reduce medium-deep wrinkles and correct lips. Its cohesiveness allows optimal adjustment to the skin, without causing a change in its structure and prevents the gel from moving. BELOTERO BALANCE 1×1.0ml are fillers with hyaluronic acid, produced using the patented Dynamic Cross-Linking Technology, thanks to which a single-phase, consistent, multi-concentrated gel (Cohesive Polydensified Matrix) is created. As a result, products with the ideal proportion are obtained: cohesiveness, elasticity and plasticity, which adapt to the appropriate layers of the skin. BELOTERO BALANCE 1×1.0ml integrates the product with the skin (the product remains at the injection site) and the product’s resistance to external forces (pressure). Advanced technology provides the ability to produce products with different characteristics depending on the needs of the target skin layer. BELOTERO BALANCE 1×1.0ml is a filler with hyaluronic acid, which can be administered using the blanching technique – so very shallowly, in the upper layers of the dermis (typical fillers are administered deeper, in the middle and deep layers of the dermis). This gives a very natural filling effect.

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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.
Quantity

1-5, 6-10, 11-20, 21+

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