HYALMASS ULTRA Lidocaine 1x1ml
Hyalmass
Dermal fillerCross-linked hyaluronic acid dermal filler with lidocaine for deep dermal injections
Certifications
- CE Marked sterile absorbable injectable dermal filler with lidocaine for aesthetic use.
- Manufactured in the Republic of Korea under medical device quality and safety controls with documented performance testing for HA concentration, pH, residual BDDE and endotoxin levels.
- Hy BRID cross Linking technology providing hyper cross Linked, non Animal hyaluronic acid gel with improved viscoelastic and volume Retention properties.
- Part of the HYALMASS dermal filler line that obtained CE certification for distribution in Europe, the Americas and other markets.
- CE Marked sterile absorbable injectable dermal filler with lidocaine for aesthetic use.
- Manufactured in the Republic of Korea under medical device quality and safety controls with documented performance testing for HA concentration, pH, residual BDDE and endotoxin levels.
- Hy BRID cross Linking technology providing hyper cross Linked, non Animal hyaluronic acid gel with improved viscoelastic and volume Retention properties.
- Part of the HYALMASS dermal filler line that obtained CE certification for distribution in Europe, the Americas and other markets.
Cross-linked hyaluronic acid dermal filler with lidocaine for deep dermal injections
Description
HYALMASS ULTRA Lidocaine 1x1ml is a high-density, cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, designed for deep dermal injections to correct deep wrinkles and folds and to provide strong structural contouring of the chin, jawline, cheeks and nose. Using Hy-BRID cross-linking technology, the Ultra formulation contains 24 mg/ml non-animal hyaluronic acid and 3 mg/ml lidocaine in a sterile, absorbable 1.0 ml prefilled syringe supplied with two 25G/27G thin-wall needles. It is CE-marked and manufactured in Korea under strict quality control with very low residual BDDE and endotoxin levels, offering long-lasting volume, defined contours and patient comfort during treatment.
Bnefits
- Provides intense volume and structural support for deep wrinkles, facial hollows and contouring indications such as chin and jawline definition.
- Formulated with 24 mg/ml cross-linked, non-animal hyaluronic acid for durable, long-lasting correction.
- Contains 3 mg/ml (0.3%) lidocaine to reduce injection pain and improve patient comfort during procedures.
- Hy-BRID cross-linking technology creates highly dense, uniform gel particles with optimal viscoelasticity and long-lasting volume retention.
- Strict manufacturing controls keep residual BDDE and endotoxin levels below detection limits, helping minimise the risk of adverse reactions.
- Supplied as a sterile, prefilled 1.0 ml syringe with two 25G/27G thin-wall needles for accurate deep-dermal placement.
- CE-marked dermal filler manufactured in the Republic of Korea for use in professional aesthetic practice.
Indications
- Deep wrinkle correction in areas such as nasolabial folds and marionette lines (within the recommended injection depth).
- Cheek augmentation and restoration of mid-face volume loss.
- Chin augmentation and projection.
- Jawline definition and contouring.
- Non-surgical rhinoplasty / nasal augmentation by experienced injectors.
- Forehead contouring and correction of selected deep forehead lines (according to practitioner assessment).
- Treatment of deep facial hollows requiring strong structural support in the deep dermis or subcutaneous plane.
Composition
- Cross-linked hyaluronic acid 24 mg/ml (non-animal origin).
- Lidocaine hydrochloride 3 mg/ml (0.3%).
- Physiological buffer with pH approximately 6.5–7.5.
- Residual BDDE (cross-linking agent) < 2 ppm (below detection limit in manufacturer testing).
- Endotoxin level < 20 EU/g (below detection limit in manufacturer testing).
Formulation
- Transparent, colourless, sterile and pyrogen-free cross-linked hyaluronic acid gel with lidocaine for injection into the deep dermis.
- High-density, highly cohesive gel produced with Hy-BRID hyper cross-linking technology, providing strong lift and contour with natural integration.
- Non-animal hyaluronic acid, homogenised for high biocompatibility and smooth extrusion.
- Packaged as a single-use prefilled 1.0 ml glass syringe, compatible with 25G and 27G thin-wall needles supplied in the box.
Packaging
- Outer carton labelled HYALMASS Hyaluronic acid – Ultra 1.0 ml, indicating CE-marked sterile absorbable dermal filler with lidocaine.
- 1 x 1.0 ml prefilled sterile glass syringe of HYALMASS ULTRA Lidocaine.
- 2 x sterile thin-wall injection needles (25G and 27G) for deep dermal / subcutaneous administration.
- Instructions for use / product information leaflet.
- Tamper-evident blister or tray packaging for syringe and needles.
Usage
- For professional use only: administer only by suitably trained and qualified healthcare professionals with expertise in facial anatomy and dermal filler injections.
- Review the patient’s medical history, allergies (especially to hyaluronic acid or amide-type local anaesthetics), current medications and previous aesthetic procedures before treatment; obtain informed consent.
- Cleanse and disinfect the treatment area thoroughly using appropriate skin antisepsis and maintain aseptic technique throughout the procedure.
- Select appropriate injection sites based on the indication (e.g., chin, cheeks, jawline, nose, deep folds) and plan vector and depth of injection in the deep dermis or superficial subcutaneous layer as recommended.
- Attach one of the supplied 25G or 27G thin-wall needles securely to the syringe, ensuring removal of any air bubbles before injection.
- Inject slowly with minimal pressure using suitable techniques such as linear threading, serial puncture, fanning or depot injections, taking care to aspirate in high-risk areas according to local protocols and to avoid intravascular injection.
- Avoid over-correction; leave a small margin to allow for post-treatment swelling.
- After injection, gently mould or massage the treated area if needed to distribute the product evenly and smooth any palpable irregularities, without excessive pressure.
- Advise patients to avoid touching or applying makeup to the treated area for several hours and to minimise exposure to extreme temperatures, saunas, sunbeds, intense exercise and alcohol for 24–48 hours.
- Ensure that appropriate emergency medications and hyaluronidase (where permitted) are available and that protocols are in place to manage vascular occlusion or other serious complications.
Contraindications
- Known hypersensitivity to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or to any component of the product.
- History of severe allergic reactions or anaphylaxis.
- Presence of active skin infection, inflammation or lesions (e.g., acne, herpes, dermatitis) at or near the planned injection site.
- Autoimmune diseases or immunosuppressive conditions where dermal filler use is considered unsuitable by the treating clinician.
- Uncontrolled bleeding disorders or use of significant anticoagulant/antiplatelet therapy where injection risk is not acceptable (subject to prescriber risk assessment).
- Pregnancy or breastfeeding, due to the lack of adequate safety data.
- Patients under 18 years of age.
- Previous permanent or unknown type filler in the same area where interactions cannot be excluded.
- Any other condition judged by the practitioner to be a contraindication to hyaluronic acid filler treatment.
Adverse Effects
- Common, usually transient effects at injection sites: erythema, swelling, tenderness, pain, itching, bruising or mild haematoma.
- Localised lumps, nodules or unevenness which may require massage, observation or, where appropriate, treatment with hyaluronidase or other measures.
- Infection at or along the injection tract, including delayed low-grade or biofilm-related infections in rare cases.
- Hypersensitivity reactions such as local or more generalised erythema, swelling or pruritus; rarely, delayed inflammatory reactions.
- Vascular compromise due to inadvertent intravascular injection or vascular compression, presenting with severe pain, blanching, livedo or tissue ischaemia/necrosis; urgent recognition and management are required.
- Very rare but serious events reported with hyaluronic acid fillers in general, including visual disturbance, retinal artery occlusion or stroke secondary to intra-arterial embolisation, requiring immediate emergency management.
- Temporary alteration of sensation or firmness in the treated area.
- In rare cases, granuloma formation or prolonged oedema.
Storage Conditions
- Store in a clean, dry place at controlled room temperature as specified on the outer carton (typically between about 1°C and 30°C or within the stated range).
- Do not freeze and protect from excessive heat and direct sunlight.
- Keep the syringe in its original blister and carton until use to maintain sterility and protect from light.
- Do not use if the packaging (outer box, blister, syringe or needle) is damaged, opened or shows signs of compromise.
- Do not use after the expiry date indicated on the packaging.
- Single-use only; discard any unused product, syringe and needles immediately after treatment in accordance with local sharps and biomedical waste regulations.
Duration
Clinical experience and supplier information indicate that results typically last around 12\u201318 months for HYALMASS Ultra, depending on treatment area, injection technique, volume used and individual patient metabolism.
Onset
Volume restoration and contouring effects are usually visible immediately after injection, with the final aesthetic outcome apparent once transient swelling, redness and bruising resolve over the following days.
