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Sculptra and Sculptra Aesthetic

by Q-Med AB EUDAMEDPMA

Active European Union and United States

PMA P030050Ref 084420

Overview

Sculptra and Sculptra Aesthetic is a dermal implant designed for aesthetic use. It is specifically indicated for the restoration and correction of signs of facial fat loss, also known as lipoatrophy, in individuals diagnosed with human immunodeficiency virus.

This device is manufactured by Q-Med AB and holds FDA PMA authorization. It is categorized as a class 3 medical device for use in plastic surgery applications.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR PMA Approved NumberP030050 Date3 Aug 2004ApprovedStatusActive
European UnionCE/MDD PMA Number— Date—StatusNot known

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Not known
  • United States FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · PMA

Trade Name
Sculptra EUDAMED
Sculptra and Sculptra Aesthetic PMA
Generic Name
Implant, dermal, for aesthetic use
Model / Reference
084420
Primary DI / UDI-DI
D-084420P5
Basic UDI-DI
B-084420P5
PMA Number
FDA Product Code
LMH
EMDN Code
X0301 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing – resorbable
Device Class
Class III
Market of Registration
Portugal
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Other devices from Q-Med AB

See all devices from Q-Med AB →

Questions

  • What is the primary use of Sculptra and Sculptra Aesthetic?

    The device is intended for the restoration and correction of facial fat loss, medically referred to as lipoatrophy, specifically in patients with human immunodeficiency virus.

  • Who is the manufacturer of this dermal implant?

    Sculptra and Sculptra Aesthetic are manufactured by Q-Med AB, based in Uppsala, Sweden.

  • Is this device FDA authorized?

    Yes, the device has received FDA PMA approval, which is the regulatory pathway for class 3 medical devices.

Properties

Show properties
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No