Skip to content
Spa Intelligence

Try a real question: “Who can inject Botox in Montana?” or “Is $12 per unit the full price?” The index loads on first use; what you type is matched in this browser.

Biostimulators

Sculptra

Galderma (PMA applicant: Q-Med AB)

FDA-approved medical device (PMA)Checked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Galderma (PMA applicant: Q-Med AB)
Category
Biostimulators
Also called
Sculptra Aesthetic, poly-L-lactic acid, PLLA

FDA status

Pathway
FDA-approved medical device (PMA)
First approved or cleared
2004

Research notes

Original PMA decision 2004-08-03; S002 (panel track) 2009-07-28; S039 approved 2023-04-25. FDA's S039 page lists contraindications including a history of keloids or hypertrophic scarring and, when reconstituted with lidocaine, lidocaine allergy. The S039 label describes the package as lyophilized vials. Sculptra is not a hyaluronic acid product.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV (original 2004 approval)
  • Correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, in people with a normal immune response (Sculptra Aesthetic, approved 2009, P030050/S002)
  • Correction of fine lines and wrinkles in the cheek region, in people with a normal immune response (approved 2023, P030050/S039)

How it’s sold

Vials of freeze-dried poly-L-lactic acid that are reconstituted with sterile water before injection

What the label warns about

Checking it’s the real thing

  • FDA advises not buying dermal fillers online (they could be counterfeit or not approved for U.S. use) and urges providers to inspect filler packages for authenticity. Page content current as of 2023-07-06.

    FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab) · publication date not recorded · checked Sep 14, 2026

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under P030050, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up P030050 and a number from the box

Check it yourself

Dermal filler proof ladder: The service uses a soft-tissue filler or sells an outcome such as facial balancing. Work down in order — each step needs the one before it.

  1. Name the fillerGet the exact product, not only material class or syringe count.
  2. Match the reviewed useCompare the product and proposed location with the FDA filler record.FDA-Approved Dermal Fillers (opens in a new tab) · U.S. Food & Drug Administration
  3. Inspect package identityThe practice should be able to show the sealed product and label before use.
  4. Verify injectorCheck the named person and applicable state license.
  5. Name complication ownershipAsk who can be reached after hours and what the written escalation route is.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA PMA database: P030050 (SCULPTRA AND SCULPTRA AESTHETIC) (opens in a new tab)FDA database
  2. FDA PMA database: P030050/S002 (SCULPTRA AESTHETIC) (opens in a new tab)FDA database
  3. FDA Recently Approved Devices: Sculptra – P030050/S039 (opens in a new tab)FDA database
  4. Sculptra labeling (FDA PMA document, S039) (opens in a new tab)Label
  5. FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

Check a name