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DEFINISSE HYDROBOOSTER (1x1ml)

DEFINISSE HYDROBOOSTER (1x1ml)

DEFINISSE

Injectable medical device
  • Class III sterile, absorbable medical device under European medical device regulations.
  • CE Marked with notified body number 0459, indicating conformity with relevant safety and performance requirements.
  • Manufactured under a certified medical device Quality Management System (e.g. ISO 13485 or equivalent).
  • Supplied sterile, single Use only, with validated sterilisation and packaging processes.
  • Professional Use Only medical device with traceability labelling (reference number, EAN/UPC, batch/lot number) as required by regulations.
Biorevitalising skin booster / mesotherapy hyaluronic acid injectable

Description

DEFINISSE HYDROBOOSTER (Relife / Menarini) is a CE-marked, sterile, resorbable, viscoelastic injectable gel implant based on high molecular weight, non-crosslinked sodium hyaluronate (hyaluronic acid) at 18 mg/ml combined with glycerol 20 mg/ml. It is a BIOREVITALIZING skin booster intended for superficial dermal / intradermal injection (mesotherapy) to compensate for age-related loss of hyaluronic acid, improve hydration, tone and elasticity of the skin, enhance skin radiance, reduce roughness and act as a filler for fine lines such as crow’s feet, smile lines and superficial perioral wrinkles. The product is supplied as a 1 ml pre-filled glass syringe with two 30G 1/2\ Terumo needles and is intended exclusively for use by trained healthcare professionals.

Bnefits

  • Biorevitalising skin booster that improves skin hydration, tone and elasticity.
  • High molecular weight hyaluronic acid (18 mg/ml) helps restore skin brightness, reduce roughness and counteract visible signs of ageing.
  • Glycerol (20 mg/ml) acts as a powerful humectant, potentiating the moisturising effect of hyaluronic acid and supporting skin elasticity.
  • Viscoelastic gel replenishes hyaluronic acid lost due to ageing, promoting firmer, more luminous and better hydrated skin.
  • Can smooth superficial fine lines and wrinkles such as crow’s feet, smile lines and superficial perioral lines.
  • Non-animal origin, fully absorbable components (sodium hyaluronate and glycerol) for good biocompatibility.
  • Suitable for multiple treatment areas including face, neck, décolleté, jawline, hands and other indicated regions.
  • Presented in a pre-filled, graduated glass syringe for precise dosing, improved stability and reduced plastic waste.
  • Intended for professional mesotherapy protocols with repeat sessions to maintain results over time.

Indications

  • Biorevitalisation (mesotherapy) for compensation of hyaluronic acid loss due to ageing.
  • Improvement of skin hydration, tone and elasticity in the superficial dermis.
  • Restoration and revitalisation of skin quality and texture on the face, neck and décolleté.
  • Treatment of fine lines and superficial wrinkles such as crow’s feet, smile lines and smoker’s lines around the mouth.
  • Refreshing and boosting skin moisture levels in targeted regions such as forehead, eye contour, cheeks, jawline, lips, neck, décolleté, hands and other suitable areas as determined by the practitioner.
  • Adjunctive treatment to enhance overall skin radiance and quality in comprehensive aesthetic protocols.

Composition

  • Non-crosslinked sodium hyaluronate (hyaluronic acid) 18 mg/ml – high molecular weight (~3 million Daltons), non-animal origin.
  • Glycerol 20 mg/ml – strong moisturising agent that supports skin elasticity and enhances the action of hyaluronic acid.
  • Phosphate-citrate buffer solution, pH approximately 6.8–7.6, q.s. to volume.
  • Water for injection and standard excipients as specified in the official Instructions for Use (IFU), without added lidocaine.

Formulation

  • Sterile, clear, colourless, viscoelastic injectable gel.
  • Based on high molecular weight, non-crosslinked sodium hyaluronate combined with glycerol.
  • Biodegradable and fully absorbable implant for intradermal / superficial dermal use.
  • Glass pre-filled syringe presentation to support product stability, haptic grip and reduced plastic contamination.
  • Class III medical device, CE-marked for professional use only.

Packaging

  • 1 x 1 ml pre-filled disposable glass syringe of Definisse Hydrobooster.
  • 2 x single-use sterile 30G 1/2" Terumo needles (CE 0197) for injection.
  • Instruction leaflet / Instructions for Use (IFU) with full indications, contraindications, precautions and directions for use.
  • Traceability labels for recording in patient notes and clinic records.
  • Outer carton labelled with brand (RELIFE DEFINISSE MENARINI GROUP), reference 9003502003846, EAN13 9003502003846 and UPC 30049000, CE mark and device classification.

Usage

  • For medical use only. Intended exclusively for healthcare professionals trained in injection techniques and familiar with facial anatomy and mesotherapy procedures.
  • Before use, carefully read the Instructions for Use (IFU) and verify integrity of the packaging, sterility and expiry date. Do not use if the sterile barrier is damaged or the product is expired.
  • Perform a full medical history including allergies (especially to hyaluronic acid or glycerol), bleeding disorders, autoimmune conditions and prior aesthetic treatments; obtain informed consent.
  • Cleanse and disinfect the treatment area according to clinic protocol. Mark the planned injection points and treatment zones (e.g. forehead, periorbital area, cheeks, jawline, neck, décolleté, hands).
  • Attach a supplied 30G 1/2" sterile needle to the pre-filled syringe using aseptic technique; expel air and check gel flow.
  • Inject small aliquots of the gel into the superficial dermis / intradermal layer using micro-papule, linear or micro-droplet techniques according to the IFU and clinical judgement, ensuring even distribution over the treatment area.
  • Avoid intravascular injection; aspirate according to local practice and take care near vessels and high-risk anatomical zones.
  • Gently massage the treated area if appropriate to ensure uniform distribution of the product.
  • Typical protocol (may vary by practitioner): repeat treatments approximately 3 times at 3-week intervals; maintenance courses can be performed up to twice per year or according to clinical assessment.
  • Provide patients with post-treatment instructions: avoid excessive sun/UV exposure, heat (sauna/steam rooms), strenuous exercise, alcohol and make-up on treated areas for at least 24 hours or as advised; avoid massaging or pressing the treated areas unless instructed.
  • Record product details (batch/lot number, syringe volume used, injection sites) in the patient’s medical record to ensure traceability.

Contraindications

  • Hypersensitivity or allergy to hyaluronic acid, glycerol or any other component of the formulation.
  • Presence of active skin infection, inflammation or disease (e.g. herpes simplex, dermatitis, acne flare) at or near the intended injection site.
  • Systemic infection, febrile illness or serious systemic disease at the time of treatment.
  • Known bleeding disorders, uncontrolled coagulation abnormalities or use of anticoagulant/antiplatelet therapy where the risk of bleeding or bruising is unacceptable in the physician’s judgement.
  • Autoimmune or connective tissue diseases or significant immunosuppression, where the treating physician considers mesotherapy inappropriate.
  • History of severe anaphylactic reactions or multiple severe allergies, unless benefit clearly outweighs risk and appropriate precautions are taken.
  • Pregnancy and breastfeeding, due to insufficient safety data in these populations.
  • Patients under the legal minimum age for aesthetic medical procedures according to local regulations.
  • Previous hypersensitivity or serious adverse reaction to injectable hyaluronic acid or similar skin boosters.

Adverse Effects

  • Common, usually transient injection-site reactions: redness (erythema), swelling, tenderness, pain, itching, small papules or bruising.
  • Localised oedema and minor hematomas at injection sites.
  • Temporary unevenness or palpable product deposits which generally resolve as the gel integrates; may require gentle massage if appropriate.
  • Infection at the injection site if aseptic technique or aftercare are insufficient, requiring medical treatment.
  • Inflammatory or hypersensitivity reactions including prolonged redness, induration or swelling; rare allergic or immune-mediated reactions may occur.
  • Very rare risk of vascular events (e.g. intravascular injection with ischaemia) if injected improperly, which require immediate specialist management.
  • As with all injectable procedures, there is a small risk of unexpected or idiosyncratic reactions that may require clinical evaluation and management.

Storage Conditions

  • Store in the original packaging in a clean, dry place at controlled room temperature, within the range specified on the outer carton.
  • Do not freeze. Avoid excessive heat, direct sunlight and temperature extremes that could impair product integrity.
  • Keep the syringe in its blister and carton until use to maintain sterility and traceability.
  • Do not use if packaging is damaged, opened or shows signs of compromised sterility.
  • Keep out of the reach of children and unauthorised persons; discard used syringes and needles as clinical sharps waste according to local regulations.

Duration

A standard course often consists of around 3 sessions spaced approximately 3 weeks apart, with results typically maintained for several months. Maintenance courses can be repeated up to about twice per year depending on patient needs, skin condition and practitioner protocol.

Onset

Hydration and radiance improvements are usually noticeable shortly after treatment, with progressive enhancement of skin quality, tone and elasticity over the weeks following a full treatment course.

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