Family profileDataset 2026.08.15.1

Radiesse

Merz Aesthetics

A source-linked identity profile for Radiesse and named catalogue variants.

Evidence status: Source-linked family dossier

The clinical research edition

Go deeper into the formulation and evidence

Explore composition, mechanism, safety and study interpretations for the exact presentation below. These new clinical drafts have a separate review process; this identity profile’s approval does not extend to them.

Radiesse monograph ↗

Identity record

What is recorded

v2026.08.15.1
Record type
Source-linked family profile
Recorded maker
Merz Aesthetics
Classification
Dermal fillerSkin booster / biostimulator
Material identity
calcium hydroxylapatite
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

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

Catalogue relationship

Matched identities and variants

2 matches

Provenance

Sources checked for this profile

3 sources · checked 14 August 2026
  1. Instructions for use

    1. Radiesse injectable implant — instructions for use

    U.S. Food and Drug Administration · United States

    Open source ↗

    Supports: Named product identity and calcium-hydroxylapatite material description for the labelled presentation.

  2. Regulator

    2. FDA-approved dermal fillers

    U.S. Food and Drug Administration · United States

    Open source ↗

    Supports: Regulatory-method context and the requirement to verify individual filler records and labels.

  3. Regulator

    3. RADIESSE injectable implant — PMA P050052

    U.S. Food and Drug Administration · United States

    Open source ↗

    Supports: The US Radiesse PMA family and supplement record for an aesthetic dermal implant.

Claim ledger

Every statement has a boundary

2 source-linked statements
  1. 1

    Identity

    Radiesse is documented in the US as an injectable implant family with a PMA supplement history.

    Scope: The statement does not treat every supplement or catalogue variant as the same presentation.

    Evidence: Radiesse injectable implant — instructions for useEvidence: RADIESSE injectable implant — PMA P050052
  2. 2

    Material / active name

    The current FDA-hosted IFU describes calcium-hydroxylapatite microspheres in an aqueous gel carrier.

    Scope: Material identity for the cited US presentation only.

    Evidence: Radiesse injectable implant — instructions for use

Use boundary

What this record does not establish

  • Regulatory statusOnly within a source's named jurisdiction; family evidence 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