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Belotero® Volume

Belotero®

Belotero® Volume

Hyaluronic acid filler with 0.3% lidocaine. According to the manufacturer's instructions for use, it is intended for improving the cheeks, temples or chin and for treating severe nasolabial folds.

  • 26 mg/ml HA
  • 0.3% lidocaine
  • 2 × 1 ml

CE-marked medical device (CE 0123) · For trained healthcare professionals only

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Description

What it is

Belotero Volume Lidocaine is an injectable, biodegradable implant of cross-linked sodium hyaluronate of non-animal origin, with 0.3% lidocaine hydrochloride. It is used to restore fullness and volume in the face.

Intended use (per instructions for use)

Intended for improving the cheeks, temples or chin, or for treating severe cases of nasolabial folds. According to the manufacturer's clinical data, the product has been shown to last up to 18 months. The purpose of the product is purely aesthetic; no clinical benefits can be expected.

Composition

Sodium hyaluronate 26 mg/ml, lidocaine hydrochloride 3 mg/ml, phosphate buffer pH 7 q.s. 1 ml. Residual BDDE ≤ 10 ppm.

Treatment

  • Contents: 2 pre-filled 1 ml syringes; each syringe is supplied with two sterile single-use needles (27G½″ and 30G½″).
  • Injection: deep into the subcutaneous layers or above the periosteum. Inject slowly, aspirate before injecting and avoid overcorrection. Maximum 8 ml per session and 16 ml per year (max 8 ml cheeks, 6 ml temples, 4 ml nasolabial folds and 5 ml chin); at least 2 weeks between injections at the same site.

Important to know

For injection only by healthcare professionals with training and knowledge of the anatomy. Contraindicated in case of known hypersensitivity to the constituents (including sodium hyaluronate, BDDE, lidocaine or other amide-type local anaesthetics), in pregnant or breastfeeding women, under 18 years of age, in case of general infection and in active autoimmune disease. Do not inject into blood vessels, into the glabella or nose area, into the orbits, eyelids and crow's feet, into the lips, to correct superficial wrinkles and lines, into skin with active inflammation or infection, or into areas previously treated with a permanent skin filler. Rare but serious events have been reported after unintentional injection into facial blood vessels (including vision impairment, blindness, stroke and skin necrosis). Single-use device; do not re-sterilise or reuse.

Storage and shelf life

Store at 2–25 °C, protected from light and dry. Avoid mechanical shocks. Do not freeze. Check the packaging and expiry date before use.

Documentation and traceability

CE-marked (CE 0123). Manufacturer: Anteis SA, Plan-les-Ouates, Switzerland. Authorised representative in the EU: Merz Aesthetics GmbH, Frankfurt am Main, Germany. See the attached Norwegian instructions for use (version 4.0, 23.02.2026).

Ingredients and composition

Composition: sodium hyaluronate 26 mg/ml, lidocaine hydrochloride 3 mg/ml, phosphate buffer pH 7 q.s. 1 ml. Residual BDDE ≤ 10 ppm. 2 × 1 ml pre-filled syringes.

Directions and protocol

Inject deep into the subcutaneous layers or above the periosteum for the cheeks, temples, chin and severe nasolabial folds. Inject slowly with the least possible pressure and use the enclosed needles (27G½″ and 30G½″ per syringe). Aspirate before injecting and avoid overcorrection. Maximum 8 ml per session and 16 ml per year (max 8 ml cheeks, 6 ml temples, 4 ml nasolabial folds and 5 ml chin); at least 2 weeks between injections at the same site. See the attached instructions for use.

Specifications

Item no.:40126
Composition: Sodium hyaluronate 26 mg/ml, lidocaine hydrochloride 3 mg/ml
Lidocaine: 0.3% (3 mg/ml)
Pack: 2 × 1 ml pre-filled syringes
Needles: 2 × 27G + 2 × 30G needles
Intended use: Cheeks, temples, chin and severe nasolabial folds
Storage: 2–25 °C, protected from light; do not freeze
Manufacturer: Anteis SA, Switzerland (EU rep. Merz Aesthetics GmbH)
Classification: CE-marked medical device (CE 0123)

Documentation and compliance

CE-marked medical device

LOT number and Declaration of Conformity accompany every shipment for your patient records.

The product information below is reserved for approved clinics. Log in

Shipping and returns

Ships from our Norwegian warehouse, typically 1 to 2 business days.

Sterile and lot-controlled goods cannot be returned for patient-safety reasons. Contact us for defects or transit damage.

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Frequently asked questions

What is the product?

Belotero Volume Lidocaine is an injectable, biodegradable implant of cross-linked sodium hyaluronate (26 mg/ml) with 0.3% lidocaine, supplied as 2 pre-filled 1 ml syringes.

What is the product intended for?

According to the instructions for use, it is intended for improving the cheeks, temples or chin, or for treating severe nasolabial folds, by injection deep into the subcutaneous layers or above the periosteum.

Which needles are included?

Each syringe is supplied with two sterile single-use needles (27G½″ and 30G½″), in total 2 × 27G½″ and 2 × 30G½″.

When must the product not be used?

Not in case of known hypersensitivity to the constituents (including sodium hyaluronate, BDDE, lidocaine or other amide-type local anaesthetics), in pregnant or breastfeeding women, under 18 years of age, in case of general infection or active autoimmune disease. Not into blood vessels, into the glabella or nose area, into the orbits, eyelids and crow's feet, into the lips, to correct superficial wrinkles and lines, into skin with active inflammation or infection, or into areas previously treated with a permanent skin filler. See the instructions for use for the full list.

How is the product stored?

At 2–25 °C, protected from light. Do not freeze. The product is for single use.

Why BC Nordic

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CE marking, Declaration of Conformity and LOT numbers ready for your compliance archive.

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