Belotero

Belotero is a family name, not one formulation or one global product list. In the United States, FDA records current to August 13, 2026 identify the original Belotero Balance system under PMA P090016 and the separately approved Belotero Volume (+) Lidocaine under PMA P250020. Balance and Volume differ in HA concentration, lidocaine configuration, labeled placement, indication, and approval history.

This page uses US FDA records as its regulatory anchor. It does not treat similarly named Belotero products sold elsewhere as US variants or as formulation equivalents.

US family at a glance

Formulation and presentation

Exact US product	Documented formulation	Lidocaine	US presentation
Belotero Balance	Bacterially fermented HA cross-linked with BDDE in two consecutively executed reactions; 22.5 mg/mL in physiologic buffer at pH 7	None	Ready-to-use, prefilled syringe; the original FDA label describes a single-use product (original FDA labeling 🔗)
Belotero Balance (+) Lidocaine	The same stated HA concentration and two-reaction BDDE-crosslinking description as Balance	0.3% lidocaine hydrochloride	1 mL of gel in a prefilled glass syringe, supplied with two sterile needles and two patient record labels (current FDA physician labeling 🔗)
Belotero Volume (+) Lidocaine	Non-animal-origin HA cross-linked with BDDE; 26 mg/mL in physiological phosphate buffer	0.3% lidocaine	Individual prefilled syringe with sterile needle(s) as indicated on the carton; the label permits a 27G 1/2-inch needle or 25G 1 1/2-inch cannula, but the cannula is not supplied. The syringe volume is stated on its label and carton rather than in the text of the FDA IFU (FDA Volume (+) physician labeling 🔗)

BDDE is 1,4-butanediol diglycidyl ether, a crosslinker used to connect HA chains into a gel network. Sharing BDDE or a family technology term does not make these formulations interchangeable. See Formulation and Gel Architecture for the fields that should be checked before comparing finished gels.

Indication, placement, and approval

Exact US product	FDA-labeled use and placement	Approval context
Belotero Balance	Mid-to-deep dermal injection for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds	Original PMA `P090016`, approved November 14, 2011 (FDA PMA record 🔗)
Belotero Balance (+) Lidocaine	Mid-to-deep dermal injection for moderate-to-severe facial wrinkles and folds, such as nasolabial folds; also volume augmentation to improve the infraorbital hollow in adults over 21. For the infraorbital indication, the FDA safety-and-effectiveness summary supports supraperiosteal and/or subcutaneous injection	Integral lidocaine approved August 29, 2019 under `P090016/S028`; infraorbital indication approved September 27, 2023 under `P090016/S050` (FDA S028 🔗; FDA S050 🔗; S050 SSED 🔗)
Belotero Volume (+) Lidocaine	Deep subcutaneous and/or supraperiosteal injection to improve mid-face volume deficit or correct mid-face contour deficiencies in adults 22 years or older	Separate PMA `P250020`, approved May 19, 2026 (FDA PMA record 🔗; FDA approval letter 🔗)

The 2023 Balance (+) expansion does not convert the non-lidocaine Balance pilot product into an FDA-approved infraorbital variant. FDA’s SSED states that the pilot study used Balance without lidocaine and the pivotal study used Balance (+); the approval order and current indication name Balance (+) for the infraorbital use (FDA S050 SSED 🔗).

FDA approval also should not be read as proof of current stock or commercial availability. The current US Belotero website foregrounds Balance (+), while the FDA PMA remains the controlling source for the approved device configurations and indications (US Belotero HCP site 🔗).

What `CPM` establishes—and what it does not

Merz uses Cohesive Polydensified Matrix (CPM) for the Belotero gel technology. The FDA patient labeling for Volume (+) describes CPM as a cross-linked HA gel with zones of different density, made through a two-step crosslinking process; the Balance label likewise describes two consecutively executed BDDE-crosslinking reactions and calls the finished product a homogeneous gel with variable-density zones (FDA Volume (+) patient labeling 🔗; FDA Balance (+) physician labeling 🔗).

CPM is useful as an attributed family and manufacturing term. It does not, by itself, establish:

identical network structure across Balance and Volume
equivalent placement, tissue response, or duration
a universal monophasic category that can be compared without a stated method
clinical superiority, easier injection, or lower complication risk

For example, FDA documents 22.5 mg/mL HA for Balance (+) and 26 mg/mL for Volume (+), while their labels authorize different treatment objectives and planes. Those facts identify different finished products; they do not form a performance ranking. Laboratory measurements need product identity and test conditions, as explained in Rheology and Physical Properties.

Safety is product- and indication-specific

The US labels contraindicate these products in patients with severe allergy histories specified in the labeling and in patients with allergy to gram-positive bacterial proteins. The lidocaine-containing variants add a contraindication for known hypersensitivity to lidocaine or amide-type anesthetics. Product use should be deferred where an active inflammatory process or infection is present (Balance (+) FDA labeling 🔗; Volume (+) FDA labeling 🔗).

Common local responses in the respective studies included swelling, bruising, pain or tenderness, redness, firmness or induration, and palpable lumps or bumps. Frequencies and follow-up periods differ between the Balance and Volume programs, so they should not be combined into a family-wide rate (Balance (+) FDA labeling 🔗; Volume (+) FDA SSED 🔗).

Both current physician labels warn that inadvertent intravascular injection can cause embolization, vascular occlusion, ischemia, or infarction. Reported serious outcomes associated with facial filler injection include temporary or permanent visual impairment, blindness, stroke, skin necrosis, and damage to underlying structures (Balance (+) FDA labeling 🔗; Volume (+) FDA labeling 🔗). These risks make product labeling, anatomy knowledge, event recognition, and an established emergency pathway essential; a family technology term does not modify that boundary.

Hyaluronidase is not a simple undo command

Hyaluronidase can enzymatically degrade many HA fillers, and the Volume (+) patient labeling lists it among treatments a clinician may consider for some adverse outcomes. That reference does not promise complete, immediate, or uniform removal (FDA Volume (+) patient labeling 🔗). Response can depend on the exact gel, enzyme preparation, exposure, amount, timing, anatomy, and the clinical problem being addressed.

Elective contour correction, suspected vascular compromise, infection, and inflammatory nodules require different clinical reasoning. Hyaluronidase should not be presented as a substitute for prevention or emergency escalation.

Company and regulatory relationships

Role	Supported US relationship
FDA applicant	Merz North America, Inc. for both `P090016` and `P250020`
Physical manufacturer named in current labels	Anteis S.A., Plan-les-Ouates, Geneva, Switzerland
US distributor named in current labels	Merz North America, Inc.
Trademark context	The US labels identify BELOTERO and MERZ AESTHETICS as registered trademarks of Merz Pharma GmbH & Co. KGaA
US commercial context	Merz Aesthetics markets the Belotero portfolio in the United States

Sources: Balance (+) FDA physician labeling 🔗, Volume (+) FDA physician labeling 🔗, and the US Belotero HCP site 🔗.

These roles should not be collapsed into the single word manufacturer. Anteis is the manufacturer named in the labels; Merz North America is the FDA applicant and named US distributor.

US and non-US names are not automatic matches

Non-US Merz portfolios can include Belotero Soft, Balance, Intense, Volume, Revive, and Lips products. A shared Belotero name or CPM description does not prove that a non-US syringe has the same concentration, lidocaine status, presentation, indications, or instructions as a US-approved product. For example, an official Merz Spain portfolio lists several of those names, but that list establishes Spanish commercial context—not US approval or cross-market formulation identity (Merz Pharma Spain product portfolio 🔗).

Use the exact local IFU or regulator record before connecting regional products. In particular:

do not shorten Belotero Volume (+) Lidocaine to a generic global Belotero Volume identity
do not map Soft, Intense, Revive, or Lips products into the US family matrix without a US approval record
do not infer that Lidocaine, (+), or an omitted suffix has the same regulatory meaning in every market
do not infer commercial availability from approval alone

Hyaluronic Acid Fillers — scope, regional identity, and reversal boundaries
Formulation and Gel Architecture — how concentration, crosslinking, lidocaine, and presentation define a finished product
Rheology and Physical Properties — how to interpret method-dependent gel measurements without creating rankings