Exact product record

JUVEDERM VOLUMA XC

Allergan Aesthetics, an AbbVie company · Prescription hyaluronic acid dermal filler

Trusted product99
FDA approval record
Regulatory statusFDA-approved prescription deviceP110033 · Approved 2013-10-22
Approved useDeep subcutaneous and/or supraperiosteal injection for cheek augmentation to correct age-related volume deficit in the midfaceAdults over age 21
MaterialTemporary crosslinked hyaluronic acid gelCrosslinked hyaluronic acid gel at 20 mg/mL with 0.3% lidocaine in a physiologic buffer
Independent trust review · spa-trust-1.0

Trusted product

This product record passed every critical evidence and disclosure gate.

99of 10085 required
6/6 gates passedReviewed Jul 18, 2026Valid until Jan 14, 2027
See validation gates and evidence
Exact product identified

The record identifies JUVEDERM VOLUMA XC rather than inferring from the broader Juvéderm family.

Required gate · 1 receipt
pass
Regulatory status verified

FDA PMA P110033 and the current directions for use are attached.

Required gate · 2 receipts
pass
Approved indication bounded

The profile limits approval claims to cheek augmentation for age-related midface volume deficit in adults over 21.

Required gate · 2 receipts
pass
Safety labeling attached

The current directions for use preserve contraindications, expected reactions, serious vascular warnings, and treatment boundaries.

Required gate · 2 receipts
pass
Periorbital transfer prohibited

The product profile explicitly prevents the cheek study from being used as evidence for under-eye filler.

Required gate · 1 receipt
pass
Current source review

The regulatory evidence was reviewed within the active trust window.

Required gate · 3 receipts
pass
Exact product identity100

Manufacturer, composition, approval number, route, and labeled anatomy are explicit.

Regulatory verification100

The FDA PMA approval and current directions for use are attached.

Labeling completeness99

The indication, population, administration boundary, contraindications, warnings, and adverse effects are included.

Product-specific evidence97

The pivotal outcomes remain tied to JUVEDERM VOLUMA XC and the labeled cheek and midface indication.

Safety disclosure99

Expected effects, contraindications, serious vascular risks, and urgent response boundaries are preserved.

Source traceability98

Every trust claim resolves to a regulator receipt.

Evidence receipts

Dermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration · regulator100%JUVEDERM VOLUMA XC Premarket Approval P110033U.S. Food and Drug Administration · regulator100%JUVEDERM VOLUMA XC Directions for UseU.S. Food and Drug Administration · regulator100%

What this does not mean

  • FDA approval does not establish that cheek or midface filler is needed or appropriate for a particular person.
  • The pivotal cheek study prohibited periorbital treatment, so this record must not be used as evidence for under-eye filler.
  • Product trust does not validate a clinic's inventory, injector, anatomy assessment, treatment plan, price, follow-up, or outcomes.
  • A Facial Harmony score or simulation cannot select the product, treatment subregion, amount, injection method, or provider.

What is verified

The FDA-reviewed pivotal study found clinically and statistically significant improvement in age-related midface volume deficit versus no treatment.

Manufacturer
Allergan Aesthetics, an AbbVie company
Administration
Provider-administered deep subcutaneous and/or supraperiosteal injection in labeled cheek and midface anatomy
Access
Prescription device administered by a trained, licensed health care practitioner

Safety boundary

Local treatment-site responses were common in the pivotal cheek study and were generally temporary. The label also preserves rare but serious intravascular complications that require prompt medical attention.

Common and expected

  • Tenderness
  • Swelling
  • Firmness
  • Lumps or bumps
  • Bruising
  • Pain
  • Redness
  • Discoloration
  • Itching

Rare but serious

  • Unintentional injection into a blood vessel
  • Embolization or vascular occlusion
  • Skin necrosis
  • Vision impairment or blindness
  • Cerebral ischemia or hemorrhage leading to stroke

Not interchangeable

  • FDA approval does not establish that cheek or midface filler is needed or appropriate for a particular person.
  • The pivotal cheek study prohibited periorbital treatment, so this record must not be used as evidence for under-eye filler.
  • Product trust does not validate a clinic's inventory, injector, anatomy assessment, treatment plan, price, follow-up, or outcomes.
  • A Facial Harmony score or simulation cannot select the product, treatment subregion, amount, injection method, or provider.

Do not use

  • Severe allergies manifested by a history of anaphylaxis or a history or presence of multiple severe allergies
  • History of allergy to gram-positive bacterial proteins
  • History of allergy to lidocaine
See candidacy, outcomes, care, and alternatives
Source ledger

3 product receipts

Dermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration · Reviewed 2026-07-13JUVEDERM VOLUMA XC Premarket Approval P110033U.S. Food and Drug Administration · Reviewed 2026-07-18JUVEDERM VOLUMA XC Directions for UseU.S. Food and Drug Administration · Reviewed 2026-07-18