Family profileClinically reviewed · indexable

Sculptra

Galderma

A source-linked identity profile for Sculptra using Galderma product and instructions-for-use 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
Galderma
Classification
Dermal fillerSkin booster / biostimulator
Material identity
poly-L-lactic acid · PLLA
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.

INTL

International / source market not limited to one jurisdiction

Manufacturer documentation

Named record

Sculptra

Galderma's international product page documents the Sculptra family and PLLA material class.

Limit: An international manufacturer overview is not a jurisdiction-specific regulatory record.

Sculptra

Catalogue relationship

Matched identities and variants

1 match

Provenance

Sources checked for this profile

3 sources · checked 14 August 2026
  1. Manufacturer

    1. Sculptra

    Galderma · International overview

    Open source ↗

    Supports: Sculptra brand identity and poly-L-lactic-acid material class.

  2. Instructions for use

    2. Sculptra — United States instructions for use

    Galderma · United States

    Open source ↗

    Supports: Labelled product identity, composition, and United States device context.

  3. Regulator

    3. SCULPTRA injectable poly-L-lactic acid — PMA P030050

    U.S. Food and Drug Administration · United States

    Open source ↗

    Supports: The US Sculptra PMA family record and its continuing supplement history.

Claim ledger

Every statement has a boundary

2 review claims
  1. 1

    Material / active name

    Sculptra is documented as an injectable poly-L-lactic-acid product family.

    Scope: Identity and material class only; no protocol, duration, outcome, or suitability claim is made.

    Evidence: SCULPTRA injectable poly-L-lactic acid — PMA P030050Evidence: SculptraEvidence: Sculptra — United States instructions for use
  2. 2

    Identity

    The FDA PMA database maintains P030050 and its supplement history for the Sculptra family.

    Scope: US regulatory record only; the latest supplement and labeling govern the exact product context.

    Evidence: SCULPTRA injectable poly-L-lactic acid — PMA P030050

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.

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