OUYE Fine Plus 1.0ml
OUYE
Medical aesthetic deviceCross-linked hyaluronic acid dermal filler with lidocaine
Certifications
- CE Marked cross Linked hyaluronic acid dermal filler with lidocaine for aesthetic indications in applicable markets.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- High Purity HA with controlled, minimal residual BDDE levels in line with international safety standards.
- Intended strictly for professional use in accordance with local regulations governing injectable aesthetic medical devices.
- CE Marked cross Linked hyaluronic acid dermal filler with lidocaine for aesthetic indications in applicable markets.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- High Purity HA with controlled, minimal residual BDDE levels in line with international safety standards.
- Intended strictly for professional use in accordance with local regulations governing injectable aesthetic medical devices.
Cross-linked hyaluronic acid dermal filler with lidocaine
Description
OUYE Fine Plus 1.0ml is a cross-linked hyaluronic acid dermal filler with lidocaine, specifically designed for the correction of fine lines and wrinkles and for subtle facial contouring and volumisation. The low- to medium-viscosity monophasic HA gel (24 mg/ml) with 0.3% lidocaine allows for precise placement in superficial to mid dermis and delicate facial areas, including periorbital lines, perioral lines and lip contours. By restoring volume and improving skin hydration, OUYE Fine Plus delivers natural-looking, refined rejuvenation with high purity, minimal residual BDDE and CE-certified safety when administered by trained medical professionals.
Bnefits
- Targets and smooths fine lines and superficial wrinkles for subtle, natural-looking rejuvenation.
- Restores lost facial volume in delicate areas such as lip borders, periorbital and perioral regions.
- Suitable for gentle facial contouring and volumisation where a softer, more refined effect is desired.
- Formulated with 24 mg/ml cross-linked hyaluronic acid for effective yet controlled volume and hydration.
- Contains 0.3% lidocaine to reduce injection pain and enhance patient comfort during treatment.
- Monophasic, homogeneous gel for smooth extrusion, even distribution and predictable results.
- High-purity HA with minimal residual BDDE to support biocompatibility and reduce risk of inflammatory reactions.
- CE-marked dermal filler produced under strict quality standards, offering a cost-effective yet reliable option.
- Clinical effect typically lasts 3–6 months, depending on treatment area, technique and individual metabolism.
Indications
- Correction of fine lines and superficial wrinkles (e.g. periorbital fine lines, perioral lines).
- Soft correction of mild nasolabial folds and marionette lines in suitable candidates.
- Subtle facial contouring and volumisation in areas requiring delicate enhancement (e.g. lip contour, vermilion border, philtral columns).
- Enhancement and definition of natural lips ("natural lips" / "Russian lips" techniques) where a softer gel is preferred.
- Improvement of skin texture and hydration in treated areas due to HA’s hydrating properties.
- Adult patients with early signs of ageing or mild volume loss seeking discreet cosmetic improvement.
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 per full IFU).
- Residual cross-linking agent BDDE present within accepted safety limits.
Formulation
- Monophasic, homogeneous cross-linked hyaluronic acid gel.
- HA concentration: 24 mg/ml.
- Lidocaine concentration: 0.3% to improve comfort during and immediately after injection.
- Viscosity profile optimised for superficial to mid-dermal injections and fine-line work.
- Sterile, pyrogen-free, viscoelastic gel supplied in a disposable glass syringe for single-patient use.
- Intended injection depth: superficial to mid dermis and/or subcutaneous plane depending on area and indication.
- Typical aesthetic effect duration: approximately 3–6 months, varying with individual factors.
Packaging
- One pre-filled sterile 1.0 ml syringe of OUYE Fine Plus.
- Two sterile 30G needles (commonly 30G 1/2" / 13 mm) included in the pack.
- Sterile blister pack with tamper-evident seal containing syringe and needles.
- Outer carton printed with product name, HA and lidocaine content, batch number and expiry date.
- Package insert (leaflet) with detailed instructions for use, indications, contraindications, precautions and storage conditions.
Usage
- OUYE Fine Plus must only be used by licensed healthcare professionals trained in dermal filler injection techniques and facial anatomy.
- Before treatment, perform a full medical history and facial assessment, discuss expectations, and obtain informed consent.
- Cleanse and disinfect the treatment area according to clinic protocol, avoiding contamination of injection sites.
- Attach one of the supplied sterile 30G needles to the pre-filled syringe using aseptic technique and expel any air bubbles.
- Recommended injection depth is superficial to mid dermis (and/or very superficial subcutaneous plane) depending on indication and anatomical area.
- Use appropriate injection techniques such as linear threading, serial puncture, fanning, micro-depot or micro-droplet techniques tailored to the area (e.g. periorbital lines, perioral lines, lip contours).
- Inject slowly with minimal pressure, carefully monitoring tissue response and patient comfort; avoid overcorrection.
- Aspirate where appropriate and always take care to avoid injection into blood vessels, especially in high-risk facial areas.
- After injection, gently massage the treated area if recommended to ensure even distribution, avoiding excessive pressure in delicate regions.
- Provide post-treatment advice: avoid touching or massaging the treated area (unless instructed), avoid makeup for several hours, and avoid excessive heat, cold, vigorous exercise, alcohol and sauna/steam for 24–48 hours.
- Instruct patients to report immediately any signs of vascular compromise (severe pain, blanching, mottling), visual disturbance, or other concerning symptoms.
- Any unused product remaining in the syringe after treatment must be discarded; do not reuse needles or syringes. Dispose of all sharps in accordance with local regulations.
- Refer to the official package insert for full instructions, recommended injection planes, maximum volumes per area, and management of potential complications.
Contraindications
- 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 infections, inflammation, acne, dermatitis or herpetic lesions at, or near, the intended injection sites.
- Autoimmune disorders or immunosuppression, unless carefully evaluated and cleared by the treating physician.
- Bleeding disorders, or concomitant use of anticoagulant or antiplatelet therapy that significantly increases bleeding risk (relative contraindication; requires risk–benefit assessment).
- Pregnancy and breastfeeding (use not recommended due to insufficient safety data).
- History of hypertrophic scarring or keloid formation in the proposed treatment areas.
- Prior permanent or unknown fillers in the treatment zone without thorough risk assessment.
- Intravascular injection is absolutely contraindicated; extra caution is required in anatomical high-risk areas (glabella, nose, periorbital region).
Adverse Effects
- Very common, usually transient injection-site reactions: redness, swelling, tenderness, itching, bruising, pain or mild warmth at the treated areas.
- Temporary lumps, bumps or irregularities due to superficial placement or localised product accumulation.
- Transient asymmetry or contour irregularity, often resolving as swelling subsides or after gentle adjustment by the practitioner.
- Nodules, granuloma-like reactions or delayed inflammatory responses in rare cases; may require medical management.
- Infection at the injection site if aseptic technique is not strictly followed.
- Vascular compromise (e.g. blanching, severe pain, livedo reticularis, tissue ischaemia or necrosis) due to intravascular injection or external compression; urgent recognition and management are required.
- Rare but serious complications reported with HA fillers in general, such as visual disturbance, retinal artery occlusion or stroke, especially when injecting near high-risk areas.
- Local or systemic allergic reactions to lidocaine or other components, including very rare risk of anaphylaxis.
- Short-term headaches or mild systemic symptoms in some patients following treatment.
Storage Conditions
- Store between 2°C and 25°C in a dry place.
- Do not freeze.
- Keep in the original packaging to protect from light and contamination until time of use.
- Do not use after the expiry date printed on the carton and syringe label.
- Do not use if the blister pack is opened or damaged, or if the syringe or solution appears compromised (e.g. discoloured, particulate matter, cracked syringe).
- Keep out of the sight and reach of children.
- Single-use medical device; do not resterilise or reuse any leftover product.
Duration
A single treatment session typically provides visible correction for approximately 3\u20136 months, depending on treatment area, injected volume, technique, and individual metabolic and lifestyle factors. Maintenance sessions may be scheduled as required following professional reassessment to sustain or optimise results.
Onset
Visible improvement in fine lines and volume is immediate after injection, with the final result becoming more apparent over several days as transient swelling and erythema resolve and the product integrates with the surrounding tissue.
