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OneFill Sub Q Hyaluron Filler 1 ml

OneFill Sub Q Hyaluron Filler 1 ml

OneFill

Injectables
  • CE Marked cross Linked hyaluronic acid dermal filler with lidocaine, in line with applicable European medical device regulations.
  • Manufactured under ISO 13485 Certified quality management systems by JDBIO Co., Ltd.
  • Developed using HCCL / HBCT crosslinking technologies aimed at enhancing durability, minimising degradation and reducing residual BDDE.
  • Formulated with premium HTL France hyaluronic acid raw material to ensure high purity and safety.
  • Marketed through professional aesthetic channels for use only by qualified medical professionals.
Hyaluronic Acid Dermal Filler

Description

OneFill Sub-Q Hyaluron-Filler 1 ml is a high-density, cross-linked hyaluronic acid dermal filler with lidocaine, engineered for deep injection and structural volumisation. Based on highly purified HA at 24 mg/ml with 0.3% lidocaine, it is designed to restore and sculpt facial contours in areas such as cheeks, chin, jawline and nose, and to correct deep-set wrinkles and folds. Utilising advanced HCCL/HBCT crosslinking technologies and premium HTL France hyaluronic acid, OneFill Sub-Q offers a stable, cohesive gel structure that provides profound volumisation, durable support and smooth integration with surrounding tissues, delivering natural-looking yet significant contouring when injected by trained medical professionals.

Bnefits

  • Designed for deep injection to provide significant volumisation and stable structural support in areas requiring contouring.
  • Formulated with a stable, high-viscosity monophasic gel structure for enduring lifting effect and projection.
  • High concentration of highly purified, cross-linked hyaluronic acid (24 mg/ml) for strong volumising capacity.
  • Contains 0.3% lidocaine to improve patient comfort during injection procedures.
  • Utilises HCCL / HBCT crosslinking technology to enhance durability, minimise degradation and reduce residual BDDE.
  • Seamlessly integrates with facial tissue for a harmonious, natural-looking contour and refined appearance.
  • Suitable for sculpting and defining cheeks, chin, jawline and nose, as well as treating deep nasolabial folds and marionette lines.
  • Manufactured using premium HTL France HA raw material for high purity and safety.
  • Supplied as a sterile, ready-to-use pre-filled syringe with sterile needles for professional use.

Indications

  • Cheeks for augmentation, lift and volume restoration.
  • Chin for augmentation and contouring.
  • Jawline for definition and contouring.
  • Nose for non-surgical correction (non-surgical rhinoplasty in appropriately selected patients).
  • Deep-set wrinkles and folds such as severe nasolabial folds and marionette lines.
  • Forehead for volumisation and smoothing of deep lines when appropriate technique and depth are used.
  • Other deep structural volumisation and contouring indications as assessed by a qualified aesthetic practitioner.

Composition

  • Cross-linked hyaluronic acid (non-animal origin), highly purified, 24 mg/ml.
  • Lidocaine 0.3% (3 mg/ml) as a local anaesthetic.
  • Physiological buffer solution and excipients to maintain isotonicity and appropriate pH.
  • Manufactured with advanced HCCL / HBCT crosslinking technologies, with BDDE residues reduced below detectable thresholds according to manufacturer data.

Formulation

  • Monophasic, high-density cross-linked hyaluronic acid dermal filler gel with lidocaine, produced using HCCL / HBCT technology to provide a highly cohesive, elastic and plastic gel for deep, subcutaneous or supraperiosteal injection, intended for structural support and significant volume restoration.

Packaging

  • 1 x 1 ml sterile pre-filled glass syringe of OneFill Sub-Q Hyaluron-Filler.
  • 2 x sterile single-use needles (typically 25G and 27G, depending on batch and market).
  • Sterile blister pack and outer carton with product labelling and instructions for use.
  • Each unit individually packaged for single-patient, single-use.

Usage

  • For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler and cannula/needle injection techniques.
  • Before treatment, obtain a complete medical history, including allergies (particularly to hyaluronic acid, lidocaine or other amide-type anaesthetics), autoimmune conditions, medications (e.g. anticoagulants/antiplatelets), prior filler treatments and any history of severe allergic reactions.
  • Clean and disinfect the treatment area following clinic aseptic protocol; maintain strict aseptic technique throughout the procedure.
  • Attach one of the supplied needles (typically 25G or 27G) securely to the pre-filled syringe, ensuring a firm connection. Prime the needle by gently expelling a small amount of gel to remove air.
  • Inject slowly using an appropriate technique for deep volumisation (e.g. supraperiosteal or deep subcutaneous bolus, linear retrograde threads, fanning or depot injections), depending on the anatomical area and practitioner judgement.
  • Continuously monitor tissue response and aspirate where deemed appropriate to reduce the risk of intravascular injection; inject small amounts per pass and avoid high-pressure injections.
  • Shape and mould the treated area gently with fingers immediately after injection, if needed, to refine contour and avoid irregularities; do not overcorrect.
  • Provide post-treatment advice, including avoiding makeup on the treated area for several hours, abstaining from strenuous exercise, alcohol, saunas, steam rooms, sunbeds and extremes of heat or cold for 24–48 hours or as per clinic guidance.
  • Advise the patient to avoid massage or pressure on the treated area unless specifically instructed, and to report any signs of vascular compromise (sudden pain, blanching, colour change, visual symptoms) immediately.
  • Schedule follow-up appointments to review results and determine if touch-up injections are required, adhering to maximum recommended volumes and intervals stated in the instructions for use.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or any excipient in the product.
  • History of severe anaphylactic reactions or multiple serious allergies without appropriate specialist assessment and precautions.
  • Injection into or near areas of active skin disease, inflammation or infection (e.g. acne, dermatitis, herpes) at the intended treatment site.
  • Presence of permanent or semi-permanent fillers or implants in the proposed treatment area, unless carefully evaluated by an experienced practitioner.
  • Autoimmune or connective tissue diseases and immunosuppression, where filler treatment should be considered with caution and specialist guidance.
  • Bleeding disorders or current use of systemic anticoagulants or antiplatelet agents that significantly increase bleeding risk, unless risk–benefit has been assessed and managed.
  • Pregnancy and breastfeeding, as the safety of hyaluronic acid fillers has not been established in these populations.
  • Do not inject into blood vessels or in high-risk vascular zones without meticulous anatomical knowledge and appropriate risk mitigation; intravascular injection is strictly contraindicated and constitutes a medical emergency if suspected.

Adverse Effects

  • Common, usually transient injection-site reactions including redness, swelling, pain, tenderness, itching, bruising, induration and mild discolouration.
  • Localised oedema or palpable lumps and nodules, which may resolve spontaneously or with gentle massage; persistent irregularities may require clinical management.
  • Temporary altered sensation, tightness or discomfort in treated areas related to injection trauma, lidocaine or local tissue response.
  • Less common adverse reactions can include delayed inflammatory nodules, granuloma formation, prolonged swelling, or delayed hypersensitivity reactions.
  • Rare but serious complications include intravascular injection leading to vascular occlusion, tissue necrosis, skin ulceration, scarring and, in high-risk areas such as the nose and glabella, potential visual impairment or blindness; practitioners must be trained in early recognition and emergency management protocols (including the use of hyaluronidase and appropriate referral).

Storage Conditions

  • Store in the original unopened packaging at the temperature range specified in the instructions for use (commonly between 2 °C and 25 °C); do not freeze.
  • Protect from direct sunlight, heat sources and excessive humidity.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the blister pack, syringe or needle packaging is damaged, opened or shows signs of compromised sterility.
  • Single-use only: do not resterilise, reuse or share any part of the syringe or needles between patients.
  • Keep out of the reach of children and unauthorised persons.

Duration

Clinical results commonly last around 12\u201318 months in deep volumisation and contouring indications (such as cheeks, chin and jawline), depending on area treated, injection technique, volume used, patient metabolism and lifestyle; retreatment intervals should be determined by the treating practitioner.

Onset

Immediate volumising and contouring effect visible after injection; final appearance typically stabilises over several days as transient swelling or redness subsides.

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