Monalisa Dermal Filler Range (Soft, Mild, Hard, Ultra)

Monalisa

Dermal Fillers

Hyaluronic acid soft tissue filler

CE Marked medical device (Monalisa dermal fillers)
Manufactured under KGMP (Korean Good Manufacturing Practice)
ISO 13485 medical device quality management certified (manufacturer level)
ISO 9001 quality management system certified (manufacturer level)

CE Marked medical device (Monalisa dermal fillers)
Manufactured under KGMP (Korean Good Manufacturing Practice)
ISO 13485 medical device quality management certified (manufacturer level)
ISO 9001 quality management system certified (manufacturer level)

Hyaluronic acid soft tissue filler

Description

Monalisa is a range of cross-linked hyaluronic acid dermal fillers developed by Genoss for the correction of fine to deep facial wrinkles, restoration of soft-tissue volume and contouring of facial features. The range includes Soft, Mild, Hard and Ultra formulations, each optimised for specific depths and indications around the mouth, lips, mid-face and other areas of volume loss. Monalisa fillers contain highly purified, non-animal hyaluronic acid with strong cross-linking chains and, in most products, 0.3% lidocaine to improve comfort during injection.

Bnefits

Restores soft-tissue volume and treats fine, medium and deep wrinkles depending on the formulation
Provides natural-looking, smooth and long-lasting aesthetic results
Based on highly purified, non-animal, cross-linked hyaluronic acid
Most products contain 0.3% lidocaine to reduce pain and discomfort during injections
High viscoelasticity and plasticity for precise contouring and shaping
Designed for stable gel structure with reduced risk of migration
CE-marked medical device with international quality certifications (e.g. KGMP, ISO 13485, ISO 9001)
Compatible with a wide range of treatment techniques and facial areas

Indications

Correction of fine, moderate and deep facial wrinkles and folds
Treatment of nasolabial folds and marionette lines
Lip augmentation, contouring and hydration
Perioral and vertical lip lines
Forehead wrinkles and glabellar (frown) lines
Periorbital lines (crow’s feet) and tear trough in appropriate indications
Chin, cheek and jawline volumisation and contouring (particularly with Hard and Ultra types)
Restoration of facial volume loss due to ageing

Composition

Cross-linked, non-animal hyaluronic acid (typically around 20–24 mg/mL depending on specific product)
Lidocaine hydrochloride 0.3% (in most Monalisa formulations with lidocaine)
BDDE (1,4-butanediol diglycidyl ether) as a cross-linking agent with very low residual level
Physiological phosphate buffer solution

Formulation

Sterile, pyrogen-free, viscoelastic, transparent and colourless hyaluronic acid gel
Pre-filled single-use glass syringe intended for injection into the dermis or subcutaneous tissue
Different viscoelastic profiles for Soft, Mild, Hard and Ultra to match indication and injection depth

Packaging

Typically supplied as 1 x 1.0 mL pre-filled single-use syringe (some variants 1.1 mL) per box
Each box generally includes 1 pre-filled syringe and 1–2 sterile single-use needles (commonly 25G, 27G and/or 30G depending on product)
Sterile blister packaging for syringe and needles
For professional use only

Usage

For administration only by appropriately trained healthcare professionals experienced in dermal filler injections
Select the appropriate Monalisa formulation (Soft, Mild, Hard or Ultra) according to treatment area, wrinkle depth and desired volumisation
Inject into the appropriate tissue plane as specified in the product instructions for use (e.g. superficial to mid-dermis for fine lines, mid- to deep dermis or subcutaneous/supraperiosteal for deeper folds and volumisation)
Use recommended needle sizes (commonly 25G–30G) and injection techniques such as linear threading, fanning, serial puncture or bolus, following manufacturer guidance
Aspirate carefully before injection to help avoid intravascular administration
Massage gently after injection if required to ensure even distribution of the gel
Do not inject into blood vessels, areas with active inflammation or infection, or regions with permanent fillers
Observe patients after treatment and provide post-procedure care advice (e.g. avoiding extreme temperatures, intense physical activity and manipulation of treated areas for a short period)

Contraindications

Hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or to any component of the product
History of severe allergic reactions or anaphylaxis
Active skin infection, inflammation or lesions at or near the intended injection site
Autoimmune diseases or uncontrolled systemic inflammatory conditions (according to physician judgement)
Tendency to develop hypertrophic scars or keloids
Pregnancy and breastfeeding (use not recommended)
Concurrent use in areas previously treated with permanent or semi-permanent fillers, unless expert assessment deems it appropriate
Known coagulation disorders or current anticoagulant/antiplatelet therapy that significantly increases bleeding risk (relative contraindication requiring risk–benefit assessment)

Adverse Effects

Transient erythema (redness), swelling and tenderness at the injection site
Pain or discomfort during and shortly after injection
Bruising or haematoma formation
Itching or local hypersensitivity reactions
Nodules, palpable lumps or unevenness in the treated area
Infection at the injection site if aseptic technique is not strictly followed
Tyndall effect (bluish discolouration) if injected too superficially
Rare but serious complications including vascular occlusion, tissue ischaemia and necrosis, or visual disturbances when inadvertently injected intravascularly

Storage Conditions

Store between 2°C and 25°C (do not freeze)
Keep in the original packaging and protect from light
Do not use if the packaging is damaged, if the syringe or needles have been previously opened, or after the expiry date
Store out of the reach of children

Duration

Typical aesthetic results last approximately 6\u201318 months depending on the specific Monalisa product used, treatment area, injection technique and individual patient factors.