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BELOTERO BALANCE

BELOTERO BALANCE

Belotero

Dermal filler
  • CE Marked medical device (Class III) under EU/UK medical device regulations.
  • FDA premarket approval (PMA) in the U.S. for treatment of nasolabial folds and, more recently, infraorbital hollowing/tear trough under Eye depressions.
  • Manufactured under sterile, GMP Compliant production standards for implantable HA Based dermal fillers.
Hyaluronic acid injectable filler

Description

BELOTERO BALANCE is a sterile, injectable hyaluronic-acid-based dermal filler provided as a viscoelastic, homogeneous gel in a pre-filled 1 mL syringe. The HA is produced via bacterial fermentation (streptococcal cultures), then cross-linked using 1,4-butanediol diglycidyl ether (BDDE), and formulated in a physiologic buffer (pH 7, 22.5 mg/mL HA). The gel integrates smoothly into the skin to temporarily correct moderate-to-severe facial wrinkles and folds such as nasolabial folds, vertical lip lines and other etched-in lines, providing plumping, wrinkle smoothing and skin surface restoration while maintaining natural skin movement and expression. The formulation is resorbable over time and may be dissolved with hyaluronidase if needed.

Bnefits

  • Immediately fills and smoothes moderate-to-severe facial wrinkles and folds (e.g., nasolabial folds, smile lines).
  • Soft, cohesive HA gel integrates into skin tissue for a natural feel and appearance, preserving normal facial expressions.
  • Safe for use in delicate and dynamic facial areas, including perioral lines and tear-trough/infraorbital hollows.
  • Resorbable over time, offering a reversible and adjustable treatment.
  • Often produces visible improvement immediately post-injection, reducing need for downtime.

Indications

  • Correction of moderate-to-severe facial wrinkles and folds, especially nasolabial (smile) lines.
  • Correction of etched-in lines such as vertical lip lines, perioral wrinkles, and marionette lines.
  • Volume augmentation in areas with volume loss or hollowness, including infraorbital / tear trough depressions (in adults over 21).
  • General soft tissue augmentation where HA-based fillers are indicated and a natural, flexible correction is desired.

Composition

  • Cross-linked Hyaluronic Acid (HA) — 22.5 mg/mL, manufactured from streptococcal cultures and cross-linked with 1,4-butanediol diglycidyl ether (BDDE).
  • Physiologic buffer solution at pH 7, used to reconstitute the filler gel.
  • Lidocaine hydrochloride 0.3% (in BELOTERO BALANCE with lidocaine) to reduce pain on injection.

Formulation

  • Sterile, non-pyrogenic, viscoelastic, colourless, homogeneous gel for intradermal/subdermal injection.
  • Prefilled 1 mL syringe, supplied with sterile needles (commonly two) for single-use injections.
  • For injection into mid-to-deep dermis (for folds and wrinkles) or appropriate superficial zones for fine lines depending on practitioner’s judgement.

Packaging

  • Prefilled single-use 1 mL glass syringe containing HA gel, sealed sterile, with sterile needles included per package.
  • Outer carton or blister pack with product labelling including batch number, expiry date, manufacturer and instructions for use.

Usage

  • Must be administered only by trained and licensed healthcare professionals experienced in facial anatomy and injectable fillers.
  • Inject into the mid-to-deep dermis for treatment of facial wrinkles and folds; use precise technique to avoid intravascular injection.
  • Avoid injection into areas with active inflammation, infection, skin eruptions, cysts or compromised skin integrity.
  • Follow aseptic technique; do not use if the syringe appears tampered, discoloured or compromised.
  • Post-treatment care: monitor for injection-site reactions; patients should avoid strenuous activity, excessive heat or other stressors for a short period as per clinician’s advice. (Standard aftercare for dermal fillers.)

Contraindications

  • History of severe allergies (e.g., anaphylaxis) or multiple severe allergic reactions.
  • Known hypersensitivity to lidocaine (if using the lidocaine-containing version) or other amide-type anaesthetics.
  • Known allergy to gram-positive bacterial proteins (since HA is derived from bacterial fermentation).
  • Active skin infection, inflammation, eruptions (cold sores, cysts, pimples, rashes, hives) in the intended injection area — treatment should be deferred until resolved.
  • Injection into blood vessels or intravascularly — to avoid vascular occlusion, infarction or embolic events.
  • Not recommended for individuals under 21 years (or per local regulatory approval age). (Standard for many dermal fillers.)

Adverse Effects

  • Injection-site reactions are common: redness, swelling, bruising, pain, tenderness, induration/pl nodules, possible asymmetry or lump formation.
  • Transient erythema, oedema, hematoma/bruising in 2.5% to more than 50% of patients in various studies.
  • Rare risk of vascular complications if improperly injected (e.g., occlusion, embolism) — requires immediate medical intervention.
  • Hypersensitivity or allergic reactions (especially in patients with HA or bacterial protein sensitivities).
  • Temporary lumpiness or migration of filler in rare cases, particularly if over-corrected or injected in high-motion areas.

Storage Conditions

  • Store as per manufacturer’s instructions, typically at controlled room temperature away from direct heat and light until use. (Standard for injectable HA fillers.)
  • Do not freeze or expose to extreme temperatures; keep sterile and sealed until ready for injection.
  • Use immediately once opened; single-use syringe must not be reused or resterilised.
  • Keep out of reach of children and unauthorised persons.

Duration

Approx. 6\u201312 months on average, depending on treatment area, injection volume, and individual metabolic factors.

Onset

Visible smoothing and plumping effect immediately after injection; final settling may take up to 1\u20132 weeks as swelling subsides.

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