Monalisa Mild Lidocaine 1x1ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
MONALISA Mild with lidocaine is the low-intermediate density variant of the hyaluronic acid filler range from Genoss Co., Ltd. (South Korea). Its 400 µm particle size places it between Soft and Hard: it is intended for moderate wrinkles and for gentle contour shaping in the mid dermis.
- Cross-linked HA 24 mg/ml
- Lidocaine 3 mg/ml (0.3 %)
- Contents 1 syringe × 1.0 ml
- Particle 400 µm
- Technology Hy-BRID
Composition and technology
- Cross-linked hyaluronic acid: 24 mg/ml, of non-animal origin, obtained by bacterial fermentation with endotoxin level control.
- Lidocaine hydrochloride: 3 mg/ml (0.3 %), pre-mixed in the syringe.
- Cross-linking agent: BDDE, with reduced residual levels according to the manufacturer.
- Hy-BRID technology: Genoss's proprietary cross-linking process, which allows the particle size of the gel to be adjusted while keeping the hyaluronic acid concentration constant. In this variant the particle size is 400 µm.
- Manufactured under ISO 13485, ISO 9001 and KGMP certification.
Differences between the MONALISA variants
All four variants share the same hyaluronic acid concentration (24 mg/ml) and lidocaine concentration (0.3 %). What distinguishes them is the particle size of the gel, and with it the viscoelasticity, the injection plane and the indication.
| Variant | Particle / plane |
|---|---|
| Soft | 200 µm — superficial dermis: fine lines, crow's feet, lip contour |
| Mild | 400 µm — mid dermis: moderate wrinkles, glabella, lip and nasal contour |
| Hard | 600 µm — mid to deep dermis: deep nasolabial fold, lip augmentation, cheekbones, chin |
| Ultra | 900 µm — deep subcutaneous: nose, chin, mandibular angle, mid-face volume |
Mild occupies the low-intermediate position: more structure than Soft, but without the projection capacity of Hard or Ultra.
Indications and treatment areas
Injectable hyaluronic acid implant for the correction of wrinkles and facial soft tissue augmentation in adult patients.
- Moderate wrinkles of the upper half of the face
- Glabellar lines
- Moderate nasolabial fold and marionette lines
- Lip contour
- Gentle shaping of the nasal and forehead contour
Technique and treatment protocol
- Injection plane: Mid dermis; in areas of thin skin, superficial to mid dermis.
- Needle: 27G in accordance with the product's distribution documentation.
- Technique: slow injection with constant pressure, using linear retrograde threading, fanning technique or discrete bolus deposits according to the indication and the plane.
- Prior aspiration in accordance with standard clinical protocol to reduce the risk of intravascular injection.
- Mould the product manually after injection to even out its distribution.
- Do not apply immediately before or after laser treatment, deep chemical peeling or dermabrasion.
- Single-use product: discard any residual content of the syringe after the session.
Genoss does not publish a single, uniform duration figure for the MONALISA range; persistence depends on the variant used, the injection plane, the area treated and individual metabolism. For that reason no numerical value is given here.
Technical data
| Manufacturer | Genoss Co., Ltd. — South Korea |
|---|---|
| Active substance | Cross-linked hyaluronic acid 24 mg/ml, non-animal origin |
| Anaesthetic | Lidocaine HCl 3 mg/ml (0.3 %) |
| Cross-linker | BDDE |
| Technology | Hy-BRID |
| Particle size | 400 µm |
| Presentation | 1 pre-filled syringe of 1.0 ml |
| Needle | 27G |
| Classification | CE-marked medical device |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C. Do not freeze. Protect from direct sunlight.
- Shelf life: 24 months in the original unopened pack.
- Do not use after the expiry date shown on the pack.
- Sterile single-use product. Do not reuse or re-sterilise.
- The pack contains: 1 pre-filled syringe of 1.0 ml, sterile needles, instructions for use and traceability labels.
Contraindications and warnings
Contraindications: pregnancy and breastfeeding; patients under 18 years of age; known hypersensitivity to hyaluronic acid, to lidocaine or to amide-type local anaesthetics; tendency to hypertrophic or keloid scarring; active skin inflammation or infection in the treatment area; active autoimmune disease; porphyria.
Precautions: do not apply in areas with pre-existing permanent implants. Assess individually in patients on anticoagulant or antiplatelet therapy, with multiple allergies or with a history of anaphylactic reactions.
Never inject intravascularly. Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the documentation of the manufacturer Genoss Co., Ltd. and its official distribution. This data sheet does not replace the instructions for use accompanying the product.