Identity
- Trade Name
- JUVEDERM VOLUMA XC FDA PMA
- Generic Name
- Implant, dermal, for aesthetic use FDA PMA
Identifiers
- PMA Number
- P110033 FDA PMA
- FDA Product Code
- LMH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Juvéderm Voluma XC is a dermal implant designed for aesthetic use, indicated for deep subcutaneous and/or supraperiosteal injection to correct age-related volume deficit in the midface. It is specifically formulated for cheek augmentation in adults over the age of 21.
The device is supplied as a sterile, single-use implant and is administered via injection by a qualified healthcare professional. It has received FDA PMA approval (P110033) and is manufactured by Allergan in Irvine, California.
Frequently asked questions
What is Juvéderm Voluma XC used for?
Juvéderm Voluma XC is indicated for deep subcutaneous and/or supraperiosteal injection to correct age-related volume deficit in the midface, specifically for cheek augmentation in adults over the age of 21, as stated in the approval documentation.
Is Juvéderm Voluma XC a single-use or reusable device?
Juvéderm Voluma XC is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and should not be resterilized or reused.
Who manufactures Juvéderm Voluma XC and where is it made?
Juvéderm Voluma XC is manufactured by Allergan, with the manufacturer's address listed as 2525 Dupont Dr., Irvine, CA 92612, based on the device data provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110033 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan
Sources (1)
- FDA PMA P110033 24 fields · synced Sep 18, 2026