OUYE SubQ Plus 1 x 1ml
OUYE
Medical aesthetic deviceCross-linked hyaluronic acid dermal filler with lidocaine
Certifications
- CE Marked hyaluronic acid dermal filler with lidocaine, manufactured to European medical device standards.
- Produced under an ISO 13485 Compliant quality management system for medical devices.
- Formulated with high Purity HA and low residual BDDE, in line with international safety guidelines for injectable fillers.
- For professional use only, subject to local regulations governing aesthetic medical devices and injectable treatments.
- CE Marked hyaluronic acid dermal filler with lidocaine, manufactured to European medical device standards.
- Produced under an ISO 13485 Compliant quality management system for medical devices.
- Formulated with high Purity HA and low residual BDDE, in line with international safety guidelines for injectable fillers.
- For professional use only, subject to local regulations governing aesthetic medical devices and injectable treatments.
Cross-linked hyaluronic acid dermal filler with lidocaine
Description
OUYE SubQ Plus 1 x 1ml is a high-viscosity, cross-linked hyaluronic acid dermal filler with lidocaine, designed for subcutaneous and deep dermal injection. It is formulated to effectively restore facial volume, smooth deep wrinkles and folds, and reshape or define facial contours, particularly in areas such as the cheeks, jawline and chin. Each syringe contains 24 mg/ml of HA gel with 0.3% lidocaine to enhance patient comfort. The dense, monophasic gel texture builds and maintains structure while providing hydration to the injected areas, delivering natural-looking yet pronounced contouring and long-lasting results, typically around 9–12+ months, when administered by trained medical professionals.
Bnefits
- High-viscosity dermal filler designed to restore significant facial volume.
- Effectively smooths deep wrinkles and folds for a rejuvenated appearance.
- Reshapes and sculpts facial contours, particularly the cheeks, jawline and chin.
- Enhances and adds definition to the high points of the face for improved profile and structure.
- Gel texture builds and maintains volume while hydrating the injected tissues.
- Contains 24 mg/ml cross-linked hyaluronic acid for robust lifting capacity.
- Includes 0.3% lidocaine to reduce pain and discomfort during injection.
- Provides natural-looking results with improved skin texture and contour.
- Delivers long-lasting outcomes, with many patients experiencing benefits for 9–12 months or longer.
Indications
- Correction of deep facial wrinkles and folds such as pronounced nasolabial folds and marionette lines.
- Restoration of volume in midface and lower face areas with moderate to severe volume loss.
- Facial contouring and reshaping of cheeks, jawline and chin.
- Enhancement and definition of high points of the face (e.g. cheekbones, chin projection) for structural refinement.
- Subcutaneous volumisation in suitable candidates requiring strong lifting and contouring effects.
- Patients seeking non-surgical facial sculpting and long-lasting correction of deep lines and volume deficits.
Composition
- Cross-linked hyaluronic acid (sodium hyaluronate) 24 mg/ml.
- Lidocaine hydrochloride 0.3% (3 mg/ml) for local anaesthetic effect.
- Physiological buffer solution including water for injection, sodium chloride and stabilising excipients (as detailed in the package insert).
- Residual cross-linking agent BDDE within internationally accepted safety limits.
Formulation
- Monophasic, homogeneous, high-viscosity cross-linked hyaluronic acid gel.
- HA concentration: 24 mg/ml, optimised for volume restoration and contouring.
- Lidocaine: 0.3% to improve comfort during and immediately after injection.
- Designed for subcutaneous and deep dermal injection planes.
- Highest viscosity filler within the OUYE Plus range, intended for structural support and pronounced lifting.
- Sterile, pyrogen-free, viscoelastic gel in a single-use pre-filled glass syringe.
- Typical aesthetic effect duration approximately 9–12 months, often exceeding 12 months depending on patient factors and treatment area.
Packaging
- 1 x 1.0 ml pre-filled sterile syringe of OUYE SubQ Plus.
- Sterile needle(s) supplied in the pack (commonly 27G, 13 mm; some distributors provide 2 x 25G needles).
- Sterile blister packaging with tamper-evident seal for syringe and needles.
- Outer carton printed with product name, HA and lidocaine content, batch number, expiry date and manufacturer details.
- Package insert with full instructions for use, indications, contraindications, warnings and storage conditions.
Usage
- OUYE SubQ Plus must only be used by licensed healthcare professionals trained in aesthetic injection techniques and detailed facial anatomy.
- Perform a thorough medical history, facial assessment and risk evaluation; obtain informed consent before treatment.
- Clean and disinfect the treatment area using appropriate antiseptic in accordance with clinic protocol.
- Attach a supplied sterile needle (typically 27G or 25G) to the pre-filled syringe using aseptic technique and expel any air bubbles.
- Recommended injection depth: subcutaneous tissue and/or deep dermis depending on the treatment area and indication.
- Use appropriate injection techniques (e.g. linear threading, fanning, depot injections, cannula techniques where applicable) tailored to areas such as cheeks, jawline, chin and deep folds.
- Inject slowly with controlled pressure, carefully monitoring tissue response and patient comfort; avoid overcorrection and adhere to recommended maximum volumes per area.
- Aspiration prior to injection may be considered where appropriate, and extra caution must be taken to avoid intravascular injection, particularly in high-risk areas.
- After injection, gently mould or shape the treated area as needed to ensure even distribution and optimal contour, avoiding excessive pressure.
- Provide post-procedure advice: avoid makeup on the treated area for several hours, avoid extreme heat/cold, vigorous exercise, sunbeds and alcohol for 24–48 hours, and avoid unnecessary manipulation of the treated regions.
- Instruct patients to seek immediate medical attention if they experience severe pain, blanching, mottling, visual disturbances, or other signs suggestive of vascular compromise.
- Dispose of any unused product, needles and syringes immediately after treatment as clinical waste in accordance with local regulations; the product is single-use only.
- Refer to the official package insert for complete instructions, contraindications and management guidance for potential adverse events.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anaesthetics, or any component of the formulation.
- History of severe anaphylactic reactions or multiple serious allergies.
- Presence of active skin infection, inflammation, acne, dermatitis or herpetic lesions at or near the intended injection sites.
- Autoimmune disorders or immunosuppressive therapy, unless carefully assessed and deemed appropriate by the treating physician.
- Bleeding disorders or concurrent use of anticoagulant/antiplatelet therapy that significantly increases bleeding risk (relative contraindication requiring risk–benefit assessment).
- Pregnancy and breastfeeding, due to lack of sufficient safety data.
- History of hypertrophic scarring or keloid formation in the planned treatment area.
- Previous permanent or unknown fillers in the same area without careful evaluation of risk (including potential interactions or nodularity).
- Absolute contraindication to intravascular injection; extra care is required in anatomically high-risk areas such as the nose, glabella and periorbital region.
Adverse Effects
- Common transient reactions at injection sites include redness (erythema), swelling, tenderness, pain, bruising, itching and warmth.
- Temporary lumps, bumps, unevenness or firmness due to localised product deposition or post-treatment swelling.
- Short-term asymmetry or contour irregularity which often improves as swelling resolves or may require minor adjustment.
- Nodules, granuloma-like reactions or delayed inflammatory responses in rare cases, potentially requiring medical treatment.
- Infection at the injection site if aseptic technique and aftercare guidance are not strictly followed.
- Vascular occlusion or compromise due to inadvertent intravascular injection or external compression, which can lead to blanching, severe pain, livedo reticularis, tissue ischaemia or necrosis if not promptly managed.
- Very rare but serious complications associated with hyaluronic acid fillers in general, such as visual disturbance, retinal artery occlusion or stroke, particularly when injecting in or near high-risk vascular territories.
- Allergic or hypersensitivity reactions to lidocaine or other components, including rare risk of systemic reactions or anaphylaxis.
- Headache, mild systemic symptoms or local discomfort in the hours to days following treatment in some patients.
Storage Conditions
- Store between 2°C and 25°C in a dry, clean environment.
- Do not freeze.
- Keep in the original blister and outer carton to protect from light and contamination until use.
- Do not use the product after the expiry date indicated on the carton and syringe label.
- Do not use if the blister or packaging is damaged, if the syringe is cracked or leaking, or if the gel appears discoloured or contains particulates.
- Keep out of the sight and reach of children.
- Single-use only; any remaining gel in an opened syringe must be discarded and must not be resterilised or reused.
Duration
Results typically last around 9\u201312 months, with many patients experiencing sustained volumising and contouring effect for 12 months or longer depending on injection site, technique, volume used, metabolic rate and lifestyle. Maintenance treatments may be scheduled following professional assessment to preserve or enhance results.
Onset
Visible improvement in volume, contour and smoothing of deep wrinkles is immediate after injection, with final aesthetic outcomes becoming clearer over several days as initial swelling and erythema subside and the gel integrates with surrounding tissues.
