Identity
- Trade Name
- Belotero Volume (+) Lidocaine FDA PMA
- Generic Name
- Implant, dermal, for aesthetic use FDA PMA
Identifiers
- PMA Number
- P250020 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
Belotero Volume (+) Lidocaine is a dermal implant classified as an implant for aesthetic use, designed to correct volume deficits or contour deficiencies in the mid-face region. It is composed of hyaluronic acid with lidocaine, intended for deep (subcutaneous or supraperiosteal) injection to restore volume and improve facial contours in adults aged 22 and older.
This device is supplied as a sterile, single-use injectable gel and is regulated under FDA Premarket Approval (PMA). It is administered in a clinical setting by trained professionals, adhering to sterile techniques. The product is available in pre-filled syringes and is intended for aesthetic procedures only, with no indication for therapeutic use. Authorisation is granted under PMA number P250020.
Frequently asked questions
What is Belotero Volume (+) Lidocaine used for in clinical practice?
Belotero Volume (+) Lidocaine is specifically authorized for deep injection (subcutaneous or supraperiosteal) to restore volume or correct contour deficiencies in the mid-face region of adults aged 22 and older. It is designed exclusively for aesthetic purposes, meaning it is not intended for therapeutic or medical treatments beyond improving facial contours.
How is Belotero Volume (+) Lidocaine supplied, and is it reusable?
Belotero Volume (+) Lidocaine is supplied as a sterile, single-use injectable gel in pre-filled syringes. Due to its sterile nature and single-use classification, it must not be reused or repackaged for multiple administrations.
What regulatory pathway does Belotero Volume (+) Lidocaine follow, and who can administer it?
Belotero Volume (+) Lidocaine is regulated under the FDA’s Premarket Approval (PMA) pathway, with approval granted under PMA number P250020. It is intended for administration by trained professionals in a clinical setting, adhering to strict sterile techniques.
Are there multiple sizes or models of Belotero Volume (+) Lidocaine available?
The provided data does not specify exact volume sizes or model variations beyond its classification as a dermal implant for aesthetic use. However, the product is supplied in pre-filled syringes, which typically vary in volume for different clinical needs. For precise sizing options, refer to the manufacturer’s packaging or technical documentation.
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: Belotero® Hyaluronfiller - Faltenbehandlung & Volumen, Belotero® - Behandlung, Kosten, Risiken | info Medizin, Belotero – Volumen und Konturen wiederherstellen | MorySkin, Belotero® - Merz Aesthetics, Belotero Soft Lidocaine | Hyaluronsäure-Filler für Volumenaufbau ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P250020 | Class III | Active |
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Manufacturer
- Manufacturer
- Merz North America, Inc.
Sources (1)
- FDA PMA P250020 23 fields · synced Sep 18, 2026