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Belotero Balance (+) Lidocaine Dermal Filler

FDA PMA

Class III (US FDA PMA)

PMA P090016

by Merz North America, Inc.

Identity

Trade Name
BELOTERO BALANCE FDA PMA
Generic Name
Implant, dermal, for aesthetic use FDA PMA

Identifiers

PMA Number
P090016 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 Balance (+) Lidocaine Dermal Filler is a dermal implant classified for aesthetic use, designed to correct moderate-to-severe facial wrinkles and folds by injection into the mid-to-deep dermis. It is formulated with hyaluronic acid and lidocaine to provide both volume augmentation and localized anesthesia. The device is intended for cosmetic enhancement, targeting areas such as nasolabial folds and infraorbital hollows in adults over 21 years old.

This device is supplied as a sterile, single-use product for professional use in clinical settings. It is approved for use in the United States under a Premarket Approval (PMA) application (P090016) and is categorized under product code LMH. The filler is intended for injection by trained healthcare providers and must be stored according to manufacturer instructions to maintain sterility 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. Sources consulted: Belotero® Hyaluronfiller - Faltenbehandlung & Volumen, PDF Belotero Balance (+) Lidocaine DERMAL Filler, BELOTERO® | Home, PDF Instructions for Use - Belotero Balance (+)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Merz North America, Inc.

Sources (1)

  • FDA PMA P090016 24 fields · synced Sep 18, 2026