Identity
- Trade Name
- RADIESSE INJECTABLE IMPLANT FDA PMA
- Generic Name
- Implant, dermal, for aesthetic use FDA PMA
Identifiers
- PMA Number
- P050052 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
Radiesse Dermal Filler is an implantable dermal device indicated for subdermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. It is classified as a dermal implant for aesthetic use under FDA device class III.
The device is supplied as an injectable implant and is authorized via FDA PMA (P050052). It is intended for use in clinical settings by qualified healthcare professionals for aesthetic correction of facial volume loss and wrinkles.
Frequently asked questions
What is Radiesse Dermal Filler used for?
Radiesse Dermal Filler is indicated for subdermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, based on the device's approval statement in the PMA documentation.
Who manufactures Radiesse Dermal Filler?
Radiesse Dermal Filler is manufactured by Merz North America, Inc., as stated in the applicant and manufacturer fields of the device data.
What regulatory authorization does Radiesse Dermal Filler have?
Radiesse Dermal Filler has FDA PMA approval, with PMA number P050052 and decision date of December 22, 2006, as shown in the authorizations and decision fields.
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. Sources consulted: RADIESSE® | Collagen Biostimulation, Merz Aesthetics: Radiesse, Radiesse® – alles zum Ablauf & Kosten - Lieb Dein Gesicht, Radiesse Filler erklärt: Wirkung, Volumen und Vorher-nachher, Radiesse® Filler - Volumen, Kontur & Kollagen Boost¹˒³˒⁵⁻¹² | Merz ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050052 | Class III | Active |
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Manufacturer
- Manufacturer
- Merz North America, Inc.
Sources (1)
- FDA PMA P050052 24 fields · synced Sep 18, 2026