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Hyaluronic acid fillers

Juvéderm Voluma XC

Allergan Aesthetics (AbbVie)

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

What it is

Maker
Allergan Aesthetics (AbbVie)
Category
Hyaluronic acid fillers
Also called
Voluma, Juvederm Voluma XC, JUVÉDERM VOLUMA XC

FDA status

Pathway
FDA-approved medical device (PMA)
First approved or cleared
2013

Research notes

PMA P110033 original approval 2013-10-22 (applicant Allergan). The PMA has 100+ supplements; indications added for Voluma XC by later supplements (if any) were not individually verified. Syringe fill volume was not confirmed from the opened label text. Trademark symbols omitted from quotes. P110033 is also the parent PMA for Volbella XC, Vollure XC, Volux XC and SkinVive.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Deep injection (under the skin and/or on the bone surface) for cheek augmentation to correct age-related volume loss in the midface, in adults over 21

How it’s sold

How it’s sold isn’t recorded for this entry.

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

  • FDA consumer update: the provider should use properly labeled, sealed vials or pre-filled syringes of FDA-approved filler; do not buy fillers sold directly to the public or use needle-free injection pens. Content current as of 2023-07-07.

    FDA Consumer Update: Dermal Filler Do's and Don'ts (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 P110033, 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 P110033 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: P110033 (JUVEDERM VOLUMA XC) (opens in a new tab)FDA database
  2. JUVÉDERM VOLUMA XC directions for use (FDA PMA document) (opens in a new tab)Label
  3. FDA: Dermal Fillers (Soft Tissue Fillers) (opens in a new tab)FDA notice
  4. FDA Consumer Update: Dermal Filler Do's and Don'ts (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