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Revolax SubQ With Lidocaine (1 x 1.1ml)

Revolax SubQ With Lidocaine (1 x 1.1ml)

Revolax

Dermal Filler
  • CE Marked Class III medical device (dermal filler with lidocaine) for use in the EU/UK and other CE Recognising markets
  • Manufactured in facilities operating under ISO 13485 Compliant quality management systems for medical devices
  • Non Animal Derived, biodegradable hyaluronic acid meeting high purity and low endotoxin specifications
  • Produced in accordance with applicable EU/UK medical device regulations and national requirements for injectable dermal fillers
  • Intended exclusively for professional use by qualified medical practitioners, in line with local regulatory and professional guidelines
Hyaluronic Acid Dermal Filler for Deep Tissue Augmentation and Facial Contouring

Description

Revolax SubQ With Lidocaine (1 x 1.1ml) is a premium, highly cross-linked, monophasic hyaluronic acid dermal filler engineered for deep subcutaneous tissue augmentation and robust facial contouring. With a high HA concentration of 24 mg/ml and 0.3% lidocaine, it is the thickest and most viscoelastic product in the Revolax range, delivering powerful lifting capacity, structural support, and long-lasting volume to areas such as the cheeks, jawline, chin, nose, and deep nasolabial folds. The smooth yet dense monophasic gel integrates evenly into dermal and subdermal tissues, allowing practitioners to sculpt and define facial features while maintaining a natural, harmonious appearance and minimising product migration. Lidocaine provides local anaesthesia for a more comfortable treatment experience and smoother injection control. Manufactured to stringent quality standards with highly purified, non-animal-derived hyaluronic acid and low endotoxin levels, Revolax SubQ is CE-marked as a Class III medical device and is designed for use by trained medical professionals for non-surgical facial rejuvenation and contouring.

Bnefits

  • Thickest and most robust filler in the Revolax range, optimised for deep volume restoration and structural support
  • High lifting capacity suitable for contouring and reshaping cheeks, chin, jawline, nose, and other areas requiring strong projection
  • Monophasic, cross-linked gel with high viscoelasticity for stable volume, shape retention, and reduced risk of migration
  • Contains 24 mg/ml non-animal hyaluronic acid and 0.3% lidocaine for effective volumisation with enhanced patient comfort
  • Designed for treatment of deep to extremely severe wrinkles, including pronounced nasolabial folds and deep facial folds
  • Results typically last approximately 12–18 months, depending on treatment area, technique, and individual metabolism
  • Highly purified HA with low endotoxin levels to reduce the likelihood of adverse reactions and improve tolerability
  • Biodegradable and non-permanent filler that is fully resorbed over time and can be dissolved with hyaluronidase if required
  • CE-marked Class III medical device manufactured under strict quality and safety standards
  • Smooth, consistent extrusion force for precise placement, even distribution, and predictable aesthetic outcomes

Indications

  • Deep to extremely severe facial wrinkles and folds, especially deep nasolabial folds and laugh lines
  • Facial contouring and augmentation of cheeks, cheekbones, and mid-face volume
  • Chin projection and reshaping for improved lower-face balance
  • Jawline definition and contouring for enhanced facial profile
  • Non-surgical rhinoplasty (nose bridge and tip contouring) where strong structural support is required
  • Deep forehead and glabellar wrinkles where a high-viscosity filler is appropriate and safe to use
  • Restoration of volume loss in areas amenable to deep subcutaneous injection and structural augmentation

Composition

  • Cross-linked, monophasic hyaluronic acid 24 mg/ml (non-animal origin, derived from bacterial fermentation)
  • Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic
  • Physiological phosphate-buffered saline as excipient
  • Highly purified HA gel with very low residual BDDE (cross-linking agent) and low endotoxin levels
  • pH and osmolality adjusted to be physiologically compatible with human tissues

Formulation

  • Sterile, apyrogenic, monophasic cross-linked hyaluronic acid gel with lidocaine for injectable use
  • High-viscosity, high-elasticity (high G’/viscoelasticity) gel designed for deep subcutaneous implantation
  • Non-animal-based, biodegradable HA polymer with dense, regular lattice structure for durability and stability
  • Single-use, prefilled 1.1 ml glass syringe with luer-lock connection and supplied 25G needles

Packaging

  • Box containing 1 x 1.1 ml prefilled glass syringe of Revolax SubQ with Lidocaine
  • 2 x 25G sterile disposable needles (commonly 25G x 13 mm, may vary by batch/market)
  • Sterile blister packaging for syringe and needles
  • Package insert with instructions for use (IFU) and safety information
  • Outer carton labelled with batch number, expiry date, CE mark, and manufacturer details

Usage

  • For professional use only: Revolax SubQ with Lidocaine must be administered by appropriately trained and licensed medical professionals experienced in dermal filler injection and facial anatomy.
  • Before treatment, obtain a full medical history, including allergies (especially to hyaluronic acid, lidocaine, or amide-type local anaesthetics), medications, bleeding disorders, autoimmune diseases, and previous aesthetic procedures.
  • Examine the treatment area, assess indications and volume requirements, and discuss realistic expectations, potential risks, and alternative options with the patient; obtain informed consent.
  • Inspect the packaging before use: do not use if the blister, syringe, or needles are damaged, opened, or past the expiry date, or if the gel shows discoloration, particulate matter, or phase separation.
  • Aseptic technique must be used throughout the procedure: disinfect hands, wear gloves, and thoroughly cleanse and disinfect the patient’s skin in the treatment area.
  • Attach the supplied 25G needle securely to the luer-lock tip of the syringe, remove air bubbles if necessary, and confirm smooth extrusion by gently depressing the plunger before injection.
  • Recommended injection depth for Revolax SubQ is the deep subcutaneous layer; avoid intravascular injection and avoid placement in superficial dermis to reduce risk of visible lumps or Tyndall effect.
  • Use appropriate injection techniques such as linear threading, fanning, cross-hatching, or small bolus injections, depending on the treatment area and aesthetic goal.
  • Inject slowly with minimal pressure, aspirating carefully according to local practice to reduce the risk of intravascular injection; do not inject into or near blood vessels.
  • Avoid overcorrection during the initial treatment session; underfill slightly to account for post-injection swelling and the possibility of touch-up treatments at a later visit.
  • After each injection, gently massage the area if needed to distribute the product evenly and smooth any irregularities, taking care not to apply excessive pressure.
  • Immediately stop injection if the patient experiences intense pain, blanching, discoloration, or other signs suggestive of vascular compromise; follow local emergency protocols and consider hyaluronidase treatment.
  • At the end of the procedure, discard any remaining product and used needles/syringe in appropriate sharps and clinical waste containers; Revolax SubQ is single-use and must not be resterilised or reused.
  • Provide post-treatment advice: avoid makeup on the treated areas for approximately 12 hours, and avoid alcohol, intense heat exposure (sauna, hot baths, sunbeds), and strenuous exercise for at least 24–48 hours.
  • Advise the patient to avoid pressure or massage on the treated areas (unless instructed), to sleep on their back where possible for the first night or two, and to protect the skin with broad-spectrum SPF.
  • Schedule follow-up as needed (usually 2–4 weeks) to assess treatment outcomes, manage any delayed reactions, and perform touch-ups if clinically indicated.
  • Instruct the patient to contact the clinic immediately if they experience severe or increasing pain, blanching or dusky skin, vision changes, signs of infection (redness, warmth, fever, pus), or other concerning symptoms.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, or other amide-type local anaesthetics, or to any component of the product
  • History of severe allergic reactions or anaphylaxis, particularly to injectable products
  • Presence of active skin infections, inflammation, herpes lesions, acne flare, or dermatitis at or near the intended injection sites
  • Patients with a tendency to develop hypertrophic scars or keloids in the treatment area
  • Pregnant or breastfeeding women (use is not recommended due to lack of safety data)
  • Patients under 18 years of age
  • Injection into blood vessels or in areas with significant vascular compromise or previous ischemic events
  • Concurrent or recent (e.g., within the previous few weeks) aggressive skin treatments on the target area, such as deep chemical peels, laser resurfacing, or dermabrasion
  • Patients with uncontrolled autoimmune diseases, severe coagulation disorders, or those on strong anticoagulation therapy, unless carefully assessed and deemed appropriate by the treating physician
  • Use in combination with other dermal fillers or implants in the same site without a clear clinical rationale and appropriate risk assessment

Adverse Effects

  • Common, usually transient injection site reactions: redness (erythema), swelling (oedema), tenderness, pain, warmth, itching, and mild bruising
  • Localized lumps, nodules, or unevenness that may require massage, observation, or, rarely, hyaluronidase treatment
  • Temporary asymmetry or over- or undercorrection of the treated area
  • Minor bleeding or hematoma at injection sites
  • Transient changes in skin sensation such as numbness or tingling due to local anaesthetic or injection trauma
  • Delayed inflammatory reactions, granuloma formation, or hypersensitivity responses (rare)
  • Infection at the injection site, including cellulitis or abscess formation (rare, risk increased with poor asepsis or patient non-compliance with aftercare)
  • Vascular complications, including intravascular injection, vessel compression, or occlusion, which may lead to blanching, pain, tissue ischemia, necrosis, or, in very rare cases, visual disturbances and blindness; these events constitute emergencies requiring immediate management
  • Allergic or pseudo-allergic reactions to lidocaine or other excipients, which may present with rash, swelling, or systemic symptoms
  • Very rare serious adverse events as may occur with any injectable HA filler, necessitating prompt medical evaluation and treatment

Storage Conditions

  • Store between 2°C and 25°C (do not freeze)
  • Keep away from direct sunlight, sources of heat, and moisture
  • Store in the original unopened blister and outer carton until use to maintain sterility and protect from light
  • Do not use if the product has been frozen, overheated, or stored outside the recommended temperature range
  • Do not use after the expiry date printed on the carton and syringe label
  • Keep out of the sight and reach of children

Duration

Approximate duration of effect is 12\u201318 months, depending on the treated area, injection technique, volume used, and individual patient factors such as metabolism and lifestyle.

Onset

Immediate volumising and contouring effect is visible at the end of the procedure, with final results apparent once initial swelling and redness subside, typically within several days to about 1\u20132 weeks.

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