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Rejeunesse Shape (1 x 1.1 ml)

Rejeunesse Shape (1 x 1.1 ml)

Rejeunesse

Dermal filler
  • CE Marked Class III medical device according to information provided by distributors and product listings.
  • Manufactured in South Korea by Newmedic Co., Ltd. under medical device quality management systems (e.g. ISO Based processes) appropriate for injectable dermal fillers.
  • Produced using advanced cross Linking and multi Step purification technologies (including high Level purification to minimise endotoxins and residual BDDE).
  • Non Animal origin hyaluronic acid filler manufactured in accordance with applicable international and regional regulations for injectable medical devices.
Cross-linked hyaluronic acid filler for deep wrinkles and facial contouring

Description

Rejeunesse Shape is a sterile, pyrogen-free, 100% cross-linked hyaluronic acid dermal filler with lidocaine, designed for the correction of deep facial wrinkles and folds as well as structural facial contouring. With a high hyaluronic acid concentration of 24 mg/ml and 0.3% lidocaine for patient comfort, this firm, high-density filler is injected into the deep dermis to superficial subcutaneous layer. It is used to volumize and sculpt areas such as the cheeks, chin, jawline and other regions with significant volume loss, while also smoothing deep lines. The non-animal hyaluronic acid gel is biodegradable and gradually resorbed by the body, providing long-lasting yet non-permanent results. Intended for professional use only in adult patients (18+) who are not pregnant, breastfeeding or allergic to its components.

Bnefits

  • High-density, 100% cross-linked hyaluronic acid (24 mg/ml) provides strong volumizing capacity and structural support for deep tissue areas.
  • Designed for deep wrinkle correction and facial contouring, including cheeks, chin and jawline, to restore youthful facial proportions.
  • Contains 0.3% lidocaine to reduce injection pain and improve patient comfort during treatment.
  • Monophasic, viscoelastic gel integrates smoothly into tissues while maintaining shape and resisting migration.
  • Non-animal origin hyaluronic acid and advanced purification technologies (e.g. multi-step/UPHEC-type purification and 8-fold purification) minimise endotoxin levels and residual BDDE, reducing risk of allergic reactions and swelling.
  • Biocompatible and biodegradable filler that is gradually broken down by the body’s enzymes, allowing for non-permanent yet long-lasting results.
  • Natural-looking effect with improved facial contours and reduction of deep lines and folds.
  • Reported clinical longevity typically ranges from about 8–12 months and, in many patients, up to 12–18 months depending on area treated, technique and individual metabolism.

Indications

  • Correction of deep facial wrinkles and folds (e.g. pronounced nasolabial folds, marionette lines).
  • Facial contouring and volumizing of the cheeks and zygomatic areas.
  • Chin augmentation and contour refinement.
  • Jawline definition and lower-face contouring in suitable patients.
  • Deep-sized depressions and volume defects in indicated facial areas.
  • Creation or enhancement of fuller lips in patients requiring a denser filler for structural support (at clinician’s discretion).
  • Restoration of facial volume in mid- to lower-face regions where deep structural support is needed.

Composition

  • Cross-linked hyaluronic acid (sodium hyaluronate) 24 mg/ml, non-animal origin.
  • Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic.
  • Phosphate-buffered saline.
  • Water for injections.
  • Trace amounts of BDDE (1,4-butanediol diglycidyl ether) as the crosslinking agent, with residual levels minimised by multi-step purification technology.

Formulation

  • Sterile, transparent, pyrogen-free, monophasic viscoelastic gel.
  • 100% cross-linked, high-density hyaluronic acid of non-animal origin.
  • Premixed with 0.3% lidocaine to enhance injection comfort.
  • Designed for injection into the deep dermis and superficial subcutaneous layer.
  • Single-use, pre-filled syringe medical device intended for professional use only.

Packaging

  • Box containing 1 pre-filled glass syringe with 1.1 ml of cross-linked hyaluronic acid gel with lidocaine.
  • Typically supplied with 1–2 sterile disposable 26G needles (needle quantity may vary by distributor; many listings specify 1 × 26G or 2 × 26G needles).
  • Syringe and needles packaged in sterile blister packaging.
  • Package insert / instructions for use (IFU).
  • Traceability labels for inclusion in patient medical records.

Usage

  • For professional use only: injections must be performed by a suitably trained and licensed healthcare professional experienced in dermal filler injection techniques.
  • Conduct a full medical history and aesthetic assessment, including indications, contraindications and patient expectations; obtain informed consent before treatment.
  • Cleanse the treatment area thoroughly and disinfect with an appropriate antiseptic solution.
  • Rejeunesse Shape is intended for injection into the deep dermis and/or superficial subcutaneous tissue using appropriate techniques such as linear threading, fanning, cross-hatching, or depot injections, depending on the area and desired contouring.
  • For deep wrinkles and folds (e.g. nasolabial folds, marionette lines), inject along the length of the fold in the deep dermis, depositing small aliquots of product while withdrawing the needle or cannula without overcorrecting.
  • For cheek and chin augmentation or jawline contouring, inject into the deep dermis or superficial subcutaneous plane with careful placement to build structural support and achieve symmetric contouring.
  • Inject slowly with gentle, controlled pressure; avoid high-pressure bolus injections and take care to remain in the intended tissue plane.
  • Where clinically appropriate, aspirate cautiously before injection to help reduce the risk of intravascular injection.
  • After injection, gently massage the treated areas as needed to ensure even distribution and a smooth contour, unless contraindicated.
  • Avoid overcorrection; it is preferable to perform touch-up sessions at a later date if additional volume is required.
  • Advise patients to avoid applying makeup on treated areas for several hours after the procedure, and to avoid saunas, extreme temperatures, intense exercise and alcohol for at least 24 hours or as directed by clinic protocol.
  • Always refer to and follow the detailed instructions, warnings and precautions in the official instructions for use (IFU) supplied with the product.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anaesthetics, or any of the excipients.
  • History of severe anaphylactic reactions or multiple severe allergies.
  • Presence of active skin infections, inflammations, herpes lesions or other dermatological diseases at or near the intended injection site.
  • Autoimmune diseases or immunocompromised conditions unless the treating physician judges that benefits outweigh potential risks.
  • Bleeding disorders, coagulation abnormalities or current use of anticoagulant or antiplatelet therapies that significantly increase bleeding risk, unless carefully evaluated by a physician.
  • Pregnancy and breastfeeding (not recommended due to lack of adequate safety data).
  • Patients under 18 years of age.
  • Previous permanent fillers or foreign bodies in the same area where interaction may pose a risk, unless evaluated by an experienced practitioner.
  • Do not inject into blood vessels, into areas with compromised blood supply, or into regions with active inflammatory or infectious processes.
  • Any general contraindications to hyaluronic acid dermal fillers or local anaesthetics as determined by the treating healthcare professional.

Adverse Effects

  • Common, usually mild and transient injection-site reactions such as irritation, redness (erythema), mild swelling, tenderness, itching or a feeling of tightness.
  • Localised pain or discomfort at the injection site, typically resolving within hours to a few days.
  • Heightened sensitivity in the treated area for a short period after injection.
  • Minor bruising or haematoma at the injection site.
  • Temporary lumps, nodules or palpable product under the skin, which often improve with gentle massage or gradually resolve.
  • Mild asymmetry or surface irregularities, which may require adjustment or touch-up treatment.
  • Less common reactions include prolonged swelling, firmness (induration), persistent redness or delayed inflammatory or hypersensitivity reactions, which may require medical management.
  • Infection at the injection site if aseptic technique is not rigorously followed.
  • Rare but serious complications, as with other dermal fillers, include accidental intravascular injection leading to tissue ischaemia or necrosis, as well as embolic events that may cause visual disturbances or blindness or, in extremely rare situations, stroke; such events require immediate emergency intervention by a qualified physician.
  • Systemic or allergic reactions to lidocaine (e.g. symptoms of local anaesthetic toxicity) may occur in susceptible individuals.
  • Any unexpected, persistent or severe adverse event should be evaluated promptly by a healthcare professional, with management guided by the product IFU and clinical best practice.

Storage Conditions

  • Store in the original packaging to protect from light and contamination until use.
  • Keep at controlled room temperature as specified in the IFU, typically between 2 °C and 25 °C.
  • Do not freeze.
  • Protect from direct sunlight and excessive heat.
  • Do not use after the expiry date printed on the packaging.
  • Use only if the syringe, blister and packaging are intact and the gel appears clear, homogeneous and free from visible particles.
  • Single-use medical device: do not resterilise and do not reuse any opened or partially used syringe.

Duration

Clinical effect is generally long-lasting, typically around 8\u201312 months and, in many patients, up to approximately 12\u201318 months depending on treatment area, injection technique, individual metabolism and lifestyle factors. Maintenance or touch-up treatments may be performed at the clinician\u2019s discretion to sustain or refine results.

Onset

Visible improvement in volume and contour is usually immediate after injection due to the filling effect of the gel, with final results becoming more evident over the following days as mild swelling or redness subsides.

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