Juvéderm Hyaluronate Gel Implants
FDA PMAClass III (US FDA PMA)
by Allergan
Identity
- Trade Name
- JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS FDA PMA
- Generic Name
- Implant, dermal, for aesthetic use FDA PMA
Identifiers
- PMA Number
- P050047 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
The Juvéderm Hyaluronate Gel Implants are classified as dermal implants for aesthetic use, designed to correct moderate to severe facial wrinkles and folds. These hyaluronic acid-based fillers are injected into the mid to deep dermis to restore volume and smooth skin contours, addressing nasolabial folds and similar imperfections.
Supplied as single-use, sterile gel implants, these devices are intended for professional use in clinical settings by trained practitioners. The product is available in multiple formulations (24HV, 30, and 30HV) and is regulated under FDA Premarket Approval (PMA P050047). Storage and handling must comply with sterile medical device protocols to ensure safety and efficacy.
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 | P050047 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan
Sources (1)
- FDA PMA P050047 24 fields · synced Oct 6, 2026