Family profileClinically reviewed · indexable

Belotero

Merz Aesthetics

A family-level profile connecting named Belotero variants in the catalogue to current manufacturer material.

Evidence status: Evidence dossier · named clinical review approved

Identity record

What is recorded

v2026.08.15.1
Record type
Source-linked family profile
Recorded maker
Merz Aesthetics
Classification
Dermal filler
Material identity
hyaluronic acid
Snapshot date
14 August 2026

Manufacturer and category are catalogue fields. They are not, by themselves, a regulatory classification or verification of the exact marketed presentation.

Jurisdiction map

What each market source establishes

Ready for clinical review

Product names and regulatory context do not travel automatically between countries. Each row below is limited to its named source market.

US

United States

Regulator record

Named record

Belotero Balance · Belotero Balance (+)

FDA records document Belotero Balance under PMA P090016, with product-specific US labeling available for the Balance presentation.

Limit: This evidence does not verify the other Belotero variants listed in the operational catalogue.

BELOTERO BALANCE — PMA P090016Belotero Balance — physician labelling

INTL

International / source market not limited to one jurisdiction

Manufacturer documentation

Named record

Belotero range

Merz's Asia-Pacific product overview documents multiple Belotero family names and a hyaluronic-acid material class.

Limit: The manufacturer overview is not a regulator record and does not establish availability or labeling in another jurisdiction.

Belotero product range

Catalogue relationship

Matched identities and variants

7 matches

Provenance

Sources checked for this profile

3 sources · checked 14 August 2026
  1. Manufacturer

    1. Belotero product range

    Merz Aesthetics · Asia-Pacific product overview

    Open source ↗

    Supports: Belotero family identity, named range context, and hyaluronic-acid material class.

  2. Approved label

    2. Belotero Balance — physician labelling

    Merz North America · United States

    Open source ↗

    Supports: Product-specific identity and composition for Belotero Balance in the United States.

  3. Regulator

    3. BELOTERO BALANCE — PMA P090016

    U.S. Food and Drug Administration · United States

    Open source ↗

    Supports: The US Belotero Balance PMA family record and supplement history.

Claim ledger

Every statement has a boundary

2 review claims
  1. 1

    Identity

    Belotero is a family identity with multiple separately named catalogue variants.

    Scope: Only Belotero Balance currently has product-specific US regulatory evidence in this dossier.

    Evidence: BELOTERO BALANCE — PMA P090016Evidence: Belotero product rangeEvidence: Belotero Balance — physician labelling
  2. 2

    Material / active name

    The cited family and Balance sources place the reviewed records in the hyaluronic-acid filler class.

    Scope: No exact composition is inferred for Intense, Lips, Revive, Soft, or Volume variants.

    Evidence: Belotero product rangeEvidence: Belotero Balance — physician labelling

Use boundary

What this record does not establish

  • Regulatory statusOnly within a source's named jurisdiction; family-profile review does not establish status elsewhere.
  • Authenticity or supply chainA catalogue name cannot authenticate an individual box, lot, or seller.
  • Clinical suitabilityNo product selection, patient assessment, dose, protocol, or injection technique is provided.
  • Availability or equivalenceNames, formulations, units, and presentations can vary by market and over time.

Separate reference from record-keeping

Document the exact product and lot actually used

Aesthetic Pass records treatment identity, lot information, photos, and injection maps. The atlas itself never chooses a product or treatment.

Explore traceability