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Restylane Skinboosters Vital Light with Lidocaine (1 x 1 ml)

Restylane Skinboosters Vital Light with Lidocaine (1 x 1 ml)

Restylane

Injectable Medical Device
  • CE Marked Class III hyaluronic acid skin booster medical device for improvement of skin quality and hydration in applicable European and international markets.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with quality and safety standards for sterile injectable medical devices.
  • Listed in regulatory registers such as the Australian Register of Therapeutic Goods (ARTG) as a synthetic Fluid tissue reconstructive material with anaesthetic for Restylane Skinboosters Vital Light Lidocaine.
  • Subject to ongoing post Market surveillance and adverse event (device vigilance) reporting in regions where it is marketed.
Hyaluronic Acid Skin Booster for Delicate / Younger or Moderately Photoaged Skin

Description

Restylane Skinboosters Vital Light with Lidocaine is a sterile, transparent injectable gel of stabilized, non-animal hyaluronic acid designed as a non-volumizing skin quality treatment. With a hyaluronic acid concentration of 12 mg/mL and 3 mg/mL lidocaine hydrochloride, it is formulated to restore skin hydrobalance, improve skin structure and enhance elasticity in younger, delicate or moderately photoaged skin. Injected into the superficial to mid dermis, it creates micro-reservoirs of moisture that deeply hydrate the skin, improving smoothness, firmness and overall texture while maintaining a natural appearance. It is particularly suited for delicate areas such as around the eyes and lips, as well as the face, neck, décolleté and backs of the hands, and is administered by certified professionals using fine micro-injections.

Bnefits

  • Deeply boosts skin hydration by replenishing dermal hyaluronic acid levels without adding significant volume.
  • Improves skin quality by increasing smoothness, elasticity and firmness in delicate or moderately photoaged skin.
  • Helps rejuvenate thin, damaged or sun-exposed skin on the face, neck, décolleté and hands.
  • Reduces the appearance of fine lines and superficial wrinkles while improving overall skin texture and tone.
  • Specifically tailored for younger or sensitive skin and delicate areas such as around the eyes and lips.
  • Contains 0.3% lidocaine to reduce injection discomfort and improve patient tolerance.
  • Uses stabilized, non-animal hyaluronic acid (NASHA technology) with an excellent safety and biocompatibility profile.
  • Provides gradual, natural-looking improvements that can be built over a series of treatments and maintained with periodic top-ups.
  • Non-permanent and reversible, with the gel gradually metabolised by the body over time.

Indications

  • Restoration of skin hydrobalance and improvement of skin structure and elasticity in younger or delicate skin.
  • Rejuvenation of damaged or delicate skin showing moderate photoageing.
  • Deep hydration and skin quality improvement of the face, including lower cheek and jawline.
  • Treatment of delicate areas such as around the eyes (periorbital area, crow’s feet) and around the lips.
  • Skin quality enhancement of the neck and upper neck region.
  • Skin quality enhancement and rejuvenation of the décolleté and upper chest.
  • Rejuvenation and hydration of the backs of the hands.
  • Treatment of fine lines in the face and other superficial wrinkles where a non-volumizing skin booster is appropriate.

Composition

  • Stabilized sodium hyaluronate (hyaluronic acid), 12 mg/mL, non-animal origin (NASHA technology).
  • Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
  • Phosphate buffered saline, q.s. to 1.0 mL.
  • Physiological sodium chloride solution, approximately pH 7.
  • Clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, non-volumizing, cross-linked hyaluronic acid gel at 12 mg/mL combined with 0.3% lidocaine hydrochloride in a physiological sodium chloride solution at pH ~7, produced using NASHA (Non-Animal Stabilized Hyaluronic Acid) technology. The gel is optimised for intradermal micro-depot injection into the superficial to mid dermis to improve skin hydration, elasticity and texture in delicate or younger skin, rather than provide structural lifting or volume.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Skinboosters Vital Light with Lidocaine.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Typically supplied with 3 fine-gauge sterile disposable needles (commonly 30G; exact specification may vary by market).
  • Luer-lock syringe with protective cap and, in many markets, the SmartClick delivery system that provides audible feedback for micro-droplet dosing.
  • Outer carton labelled with product name, volume, batch/lot number, expiry date, manufacturer details and regulatory markings.
  • Traceability / patient record labels included for insertion into the patient’s medical records.

Usage

  • For professional use only: Restylane Skinboosters Vital Light with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in intradermal injection techniques and anatomy of the treatment areas.
  • Before use, visually inspect the outer carton, blister and syringe. Do not use if any component is damaged, sterility is in doubt, the gel appears cloudy or contains visible particles, or the product is past its expiry date.
  • Obtain a complete medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease, previous fillers or skin treatments, and current medications (particularly anticoagulants and antiplatelet agents).
  • Thoroughly cleanse and disinfect the treatment area (e.g. face, periorbital region, neck, décolleté, hands) according to clinic protocols for injectable procedures.
  • Attach a suitable fine-gauge sterile needle (often 30G) or compatible micro-cannula securely to the luer-lock syringe using aseptic technique, and expel any air from the system before injection.
  • Inject small aliquots into the superficial to mid dermis using micro-depot, serial puncture, linear threading or nappage techniques, distributing the product evenly in a grid or pattern appropriate for the treatment area.
  • Inject slowly with gentle, controlled pressure and aspirate where appropriate, even though the target is intradermal, to minimise the risk of inadvertent intravascular injection.
  • Avoid overcorrection; the aim is uniform improvement in skin quality rather than visible volumization. Spread the total dose across the treatment area based on clinical judgement and instructions for use.
  • Gently massage or smooth the treated area if necessary to help distribute the gel and reduce palpable deposits, avoiding excessive pressure, especially in delicate regions such as around the eyes.
  • Do not inject into areas with active skin disease, inflammation or infection (e.g. dermatitis, acne, bacterial infection, herpes lesions). If severe pain, blanching, visual symptoms or other signs of vascular compromise occur, stop the injection immediately and manage according to current clinical guidelines.
  • A typical treatment program consists of an initial course of three sessions spaced about 2–4 weeks apart. Clinical improvements may be visible after the first session but are more pronounced after completion of the series.
  • After the initial series, maintenance treatments are usually recommended approximately every 4–6 months, or as needed based on the patient’s response and local protocols, to sustain skin quality benefits.
  • Post-treatment, advise patients to avoid makeup on the treated area for several hours, and to avoid extremes of temperature, sunbeds, saunas, vigorous exercise, alcohol, and manipulation or massage of the treated areas for a short period according to clinic guidelines.
  • Document the procedure in the patient’s record, including product name, batch/lot number, treatment areas, injection technique, total volume used and any immediate reactions, using the supplied traceability labels.

Contraindications

  • History of severe allergies or anaphylactic reactions, or presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any other component of the product, including gram-positive bacterial proteins.
  • Bleeding disorders or concurrent significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin disease, inflammation, infection or lesions at or near the intended injection sites (e.g. dermatitis, acne, bacterial infection, viral lesions such as herpes).
  • Intravascular injection is strictly contraindicated; the product must never be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended for intradermal use in the superficial to mid dermis only, as specified in the Instructions for Use.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers or skin boosters.
  • Use during pregnancy or breastfeeding is not recommended because of insufficient safety data.
  • Use in patients below the minimum age specified in the product labelling and local regulations (typically adults aged 18 years or older).

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Small papules, lumps or nodules at injection sites, which typically resolve as the product integrates but may occasionally persist and require further management.
  • Injection-site hematoma or ecchymosis, particularly in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
  • Temporary changes in sensation such as numbness, tingling or tightness in the treated area due to lidocaine and injection trauma.
  • Localized inflammatory reactions including swelling, redness and warmth, which may occur immediately or be delayed and generally resolve spontaneously within days to a few weeks.
  • Infection at or near the injection site if aseptic technique and aftercare instructions are not strictly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require medical treatment and, in some cases, hyaluronidase.
  • Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss, which require urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or other changes in skin pigmentation and texture, particularly in susceptible individuals.
  • Unsatisfactory cosmetic outcome or asymmetry that may necessitate additional treatments or corrective procedures.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at a controlled temperature, generally between 2°C and 25°C, as indicated in the product packaging and Instructions for Use.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the sterile blister or syringe packaging has been opened or damaged prior to use.

Duration

Following a standard course of three sessions, improvements in skin hydration, elasticity and texture typically last up to about 6\u20139 months, and in some patients up to approximately 12 months, depending on individual factors, treatment area, technique and maintenance schedule.

Onset

Initial improvement in hydration and radiance is often noticeable shortly after treatment, with progressive enhancement of skin smoothness, elasticity and fine lines over subsequent weeks as the hyaluronic acid integrates into the dermis and binds water; full effect is usually evident after completion of the initial treatment series.

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