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Belotero Revive Dermal Filler by Merz Aesthetics 1x1ml

Belotero Revive Dermal Filler by Merz Aesthetics 1x1ml

Belotero

Injectable dermal filler
  • CE Marked medical device (hyaluronic acid dermal filler/skin booster) in applicable markets within the EU/EEA and countries recognising CE certification.
  • Manufactured under Good Manufacturing Practice (GMP) and ISO Compliant quality management systems for medical devices.
  • Belotero portfolio recognised as consisting of fully biocompatible and bioresorbable fillers manufactured in Germany by Merz.
  • Complies with relevant safety and performance requirements for injectable HA dermal implants/skin boosters in markets where authorised.
  • Supported by clinical evidence demonstrating improvements in skin hydration, elasticity, roughness and redness in photodamaged or ageing skin.
Hyaluronic acid skin booster with glycerol

Description

Belotero Revive Dermal Filler by Merz Aesthetics is a CE-marked, cross-linked hyaluronic acid (HA) skin booster specifically designed to treat early signs of photodamaged and dehydrated facial skin. It combines 20 mg/ml cross-linked sodium hyaluronate (non-animal origin) with 17.5 mg/ml glycerol in a phosphate buffer, providing deep, long-lasting hydration and improving skin elasticity, firmness, and radiance. Used predominantly as a mesotherapy-style skin revitaliser rather than a volumising filler, Belotero Revive targets dullness, rough texture, fine/superficial lines, and early sagging while preserving natural facial expression. Supplied as a 1 ml prefilled sterile syringe, it is intended exclusively for trained healthcare professionals for intradermal/superficial dermal injection over a series of sessions, delivering up to approximately 9 months of improved skin quality and glow.

Bnefits

  • Deep and long-lasting skin hydration thanks to the combination of cross-linked hyaluronic acid and glycerol, helping to restore the skin’s moisture balance.
  • Improves skin elasticity and firmness, making the skin appear more supple and resilient.
  • Reduces superficial and fine lines associated with early photoageing and dehydration, especially on sun-exposed facial areas.
  • Enhances overall skin quality, including tone, radiance, and smoothness, leading to a fresher, more luminous complexion.
  • Helps reduce redness and surface roughness associated with photodamaged or stressed skin.
  • Acts as a preventative skin booster to slow progression of early aesthetic changes, suitable for early intervention in younger or mildly aged skin.
  • Non-animal, cross-linked HA formulation with glycerol for a strong humectant effect, supporting barrier function and reducing transepidermal water loss.
  • Designed for a series of minimally invasive treatments with relatively short downtime and high patient satisfaction.
  • Provides natural-looking results without excessive volumisation, preserving normal facial movement and expression.

Indications

  • Treatment of early signs of photodamaged facial skin characterised by dehydration, loss of elasticity, superficial fine lines and roughness.
  • Skin revitalisation and hydration of the face in adults, particularly in patients with dull, lacklustre or stressed skin.
  • Improvement of skin quality and fine lines in specific facial areas: cheekbones, cheeks, nose area, corners of the mouth, and chin.
  • Skin quality improvement in other regions such as neck, décolletage and hands, where allowed by local labelling and professional judgement.
  • Preventative or early aesthetic intervention to maintain skin hydration and delay visible signs of ageing in suitable patients.
  • Adjunctive treatment in aesthetic regimens to improve texture and radiance in combination with other modalities (as per practitioner protocols and local regulations).

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 20 mg/ml, of non-animal origin.
  • Glycerol 17.5 mg/ml (humectant to enhance and prolong hydration).
  • Physiological phosphate buffer, pH approximately 7, q.s. to 1.0 ml.
  • Sterile, apyrogenic, viscoelastic, colourless, transparent gel formulation.
  • Latex-free, bioresorbable implant intended for intradermal/superficial dermal use.

Formulation

  • Sterile, non-pyrogenic, viscoelastic cross-linked hyaluronic acid gel containing glycerol in a phosphate buffer.
  • Transparent, colourless injectable skin booster designed for superficial dermal injection (e.g., microdroplet or mesotherapy-like techniques).
  • Non-animal derived sodium hyaluronate (20 mg/ml) with 17.5 mg/ml glycerol for prolonged hydration and improved skin quality.
  • Single-use, prefilled 1 ml syringe intended for use by trained healthcare professionals only.
  • Bioresorbable dermal implant with a balance of cohesivity, elasticity and plasticity, allowing even integration into the superficial dermis.

Packaging

  • 1 x 1 ml prefilled glass syringe of Belotero Revive (cross-linked sodium hyaluronate 20 mg/ml + glycerol 17.5 mg/ml in phosphate buffer).
  • Typically supplied with one or more sterile disposable needles (often 30G for superficial dermal injection) as specified in the local Instructions for Use.
  • Syringe and accessories sealed in a sterile blister pack to maintain sterility until use.
  • Outer cardboard carton with product name, batch/lot number, expiry date and regulatory markings (including CE mark and manufacturer info).
  • Package insert / Instructions for Use (IFU) containing detailed indications, contraindications, warnings and injection guidance; patient information documents may be included depending on market.

Usage

  • For professional use only: Belotero Revive must be injected exclusively by appropriately trained and qualified healthcare professionals familiar with facial anatomy and injectable HA skin boosters.
  • Recommended injection depth is superficial dermis/intradermal, using a microdroplet, papular, linear threading or mesotherapy-style technique according to the current Instructions for Use and professional training.
  • A typical protocol involves a series of 1–3 treatment sessions, generally using 1 ml per session, spaced approximately 4 weeks apart; maintenance sessions can be performed approximately every 6–12 months depending on clinical response and local guidance.
  • Before treatment, take a full medical history and assess for contraindications (e.g., allergies, autoimmune disease, pregnancy, infection at the intended site). Obtain informed consent.
  • Prepare the skin with appropriate cleansing and antisepsis, and maintain strict aseptic technique throughout the procedure.
  • Inject slowly with minimal injection pressure, placing small aliquots into the superficial dermis; avoid overcorrection and distribute the product evenly over the treatment area.
  • Common treatment areas include cheekbones, cheeks, nose area, corners of the mouth and chin; in some protocols, neck, décolletage and hands may also be treated where permitted by local labelling.
  • After injection, gently massage or smooth the treated area if recommended in the IFU to ensure even distribution and reduce the risk of palpable irregularities.
  • Do not inject into blood vessels. Use appropriate aspiration techniques and an awareness of vascular anatomy to minimise the risk of intravascular injection and subsequent ischaemic complications.
  • Advise patients to avoid makeup, intensive exercise, sauna/steam rooms, alcohol excess and direct sun or heat exposure for the first 24 hours after treatment, and to follow any additional aftercare instructions supplied in the IFU.
  • Single-use device: do not resterilise or reuse. Any unused product and used sharps should be disposed of in accordance with local regulations and clinical waste protocols.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, glycerol, phosphate buffer components, or any other ingredient of the product.
  • History of severe allergies, anaphylactic reactions, or multiple severe hypersensitivities.
  • Patients with autoimmune diseases or under significant immunosuppressive therapy, unless the potential benefits and risks have been carefully assessed in line with local guidance.
  • Pregnant or breastfeeding women (use is generally not recommended due to lack of adequate safety data).
  • Patients under 18 years of age.
  • Presence of active infection, inflammation, or skin disease (e.g., acne, herpes, dermatitis) at or near the intended injection site.
  • Active systemic infection or acute febrile illness.
  • Known tendency to develop hypertrophic scars or keloids, or history of severe scarring disorders in treatment areas.
  • Previous treatment with permanent or non-resorbable fillers in the intended injection area (increased risk of delayed reactions and nodules).
  • Known bleeding disorders, significant coagulation abnormalities, or current use of anticoagulants/antiplatelet agents without individual risk assessment.
  • Any contraindications listed in the official Belotero Revive Instructions for Use and local regulatory labelling, including strict avoidance of intravascular injection.

Adverse Effects

  • Very common, usually transient injection-site reactions such as erythema (redness), swelling, oedema, pain, tenderness, itching, warmth, bruising or minor bleeding at the injection site.
  • Transient papules or small bumps at injection points due to superficial placement of microdroplets, generally resolving within days.
  • Local induration, firmness, palpable product or nodules at or near the injection area.
  • Asymmetry, irregularities in skin surface, or over- or under-correction requiring massage or further management.
  • Injection-site discoloration, ecchymosis or haematoma.
  • Local inflammatory reactions or hypersensitivity responses, which in rare cases may be prolonged or recurrent.
  • Infection at the injection site, including rare abscess formation or delayed biofilm-associated reactions.
  • Granuloma formation or delayed inflammatory nodules, which may require specific medical management.
  • Very rare but serious complications arising from inadvertent intravascular injection (e.g., vascular occlusion, tissue ischaemia or necrosis, visual disturbance or blindness, stroke-like events); these are medical emergencies and require immediate management according to current best practice.
  • Other adverse events listed in the official Belotero Revive Instructions for Use and post-marketing safety information.

Storage Conditions

  • Store in accordance with the manufacturer’s labelling, typically at controlled room temperature within the range stated on the carton (commonly around 2–25 °C).
  • Do not freeze the product; avoid excessive heat and protect from direct sunlight and extreme temperature fluctuations.
  • Keep the syringe in its original sterile blister and outer carton until use to maintain sterility and protect from light.
  • Do not use if the packaging is damaged, if the syringe appears compromised, or if the expiry date printed on the pack and label has passed.
  • Single-use device: once opened and used for a single patient, any remaining gel must be discarded; never resterilise or reuse.
  • Store out of the reach of children and non-professional users.

Duration

Hydration and skin-quality improvement typically last up to approximately 6\u20139 months, with many patients experiencing sustained benefits (hydration, smoothness, radiance) for around 9 months depending on age, skin type, lifestyle, treatment area, and technique; maintenance treatments are often recommended every 6\u201312 months.

Onset

Most patients notice immediate or very early improvements in hydration and skin glow after the first session, with progressive enhancement of texture, elasticity and radiance over the following weeks and across a full course of 2\u20133 sessions.

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