Cross-linked hyaluronic acid dermal filler with lidocaine for fine to moderate facial lines
Certifications
CE Marked medical device for dermal filler use (device CE certificate including CE 2265 reference in IFU)
Class III medical device classification in EU/EEA registries for cross Linked hyaluronic acid dermal fillers with lidocaine
Hyaluronic acid raw material documented as pharmaceutical grade with FDA Drug Master File (DMF) and EDQM certification
CE Marked medical device for dermal filler use (device CE certificate including CE 2265 reference in IFU)
Class III medical device classification in EU/EEA registries for cross Linked hyaluronic acid dermal fillers with lidocaine
Hyaluronic acid raw material documented as pharmaceutical grade with FDA Drug Master File (DMF) and EDQM certification
Manufactured under quality Management systems consistent with medical Device regulatory requirements (e.g., ISO 13485 and related standards, per manufacturer disclosures)
Needles supplied with the kit carry their own CE Marking (e.g., CE 0068) according to the IFU
Description
LAPIENA Classic is a CE-marked, cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, developed using HCCL™ (high cohesive cross-linking) technology. It is the softest and thinnest filler in the Lapiena range and is intended for the correction of fine to moderate facial lines and subtle volume restoration. Supplied as a sterile, single-use 1.0 ml pre-filled syringe, it provides natural-looking correction with immediate, long-lasting results and enhanced patient comfort due to the integrated local anaesthetic.
Bnefits
Targets fine to moderate facial lines while maintaining a soft, natural look
Immediate visible correction with little or no downtime for most patients
Balanced cohesivity, elasticity and plasticity for precise contouring and controlled placement
HCCL™ technology designed to reduce residual BDDE, improve stability and minimise post-treatment swelling
Contains 0.3% lidocaine to reduce injection-related pain and improve patient comfort
CE-marked medical device with clinical data supporting safety and effectiveness for nasolabial folds
Uses pharmaceutical-grade hyaluronic acid with FDA DMF and EDQM approvals for the raw material
Can be combined with other Lapiena variants (Deep, Sub-Q) for layered or full-face treatment strategies
Long-lasting results compared with many non-cross-linked HA injectables (exact duration patient-dependent)
Indications
Correction of fine wrinkles and restoration of facial volume in adults over 21 years of age
Treatment of fine to moderate facial lines and folds
Nasolabial folds and other mild volume deficits in the mid-face
Crow’s feet
Glabella (glabellar) lines, excluding the high-risk central glabella vascular zone for intravascular injection
Perioral (smoker’s) wrinkles
Horizontal forehead lines
Tear troughs and under-eye fine lines (not the periorbital soft-tissue danger zones specified as contraindicated for this product series in general IFU; use only as per local guidance and injector training)
Manufactured under quality Management systems consistent with medical Device regulatory requirements (e.g., ISO 13485 and related standards, per manufacturer disclosures)
Needles supplied with the kit carry their own CE Marking (e.g., CE 0068) according to the IFU
Cross-linked hyaluronic acid dermal filler with lidocaine for fine to moderate facial lines
Marionette lines and other superficial to medium-depth facial wrinkles
Phosphate buffer saline solution with excipients, pH approximately 7, q.s. to 1.0 ml
Formulation
Sterile, pyrogen-free, highly viscous water-based gel of cross-linked hyaluronic acid with 0.3% lidocaine
Pre-filled single-use 1.0 ml syringe for intradermal injection
Intended for injection into the medium dermis (and upper dermis for fine lines) by trained medical professionals only
Packaging
1 x 1.0 ml pre-filled syringe of LAPIENA Classic gel
1 x 27G 13 mm needle
1 x 30G 13 mm needle
Sterile blister and outer carton with instructions for use and CE-marking information
Usage
Only licensed and appropriately trained healthcare professionals should administer LAPIENA Classic.
Before treatment, take a detailed medical history, assess indications and exclude contraindications such as pregnancy, hypersensitivity to HA or lidocaine, and active skin infection.
Store the syringe as directed and allow it to reach room temperature (approximately 30 minutes) before use.
Disinfect the treatment area thoroughly and maintain strict aseptic technique throughout the procedure.
Attach the supplied sterile needle securely to the syringe and expel a small drop of gel to remove air before injection.
Inject slowly into the appropriate dermal plane (typically the medium dermis; upper dermis for very fine lines) using linear threading, serial puncture or other appropriate injection techniques, while aspirating and avoiding intravascular placement.
Massage the treated area gently after injection to ensure even distribution and integration of the gel, without applying excessive pressure.
Do not over-correct at the initial session; perform touch-up treatment immediately or after a few weeks if necessary, based on clinical assessment.
Advise patients to avoid makeup for at least 12 hours after treatment and to avoid intense sun/UV exposure, extreme heat or cold, saunas and vigorous exercise for around 2 weeks.
Instruct patients to monitor for persistent redness, pain, swelling or other unexpected reactions and to seek medical attention if symptoms last longer than one week or worsen.
Dispose of used needles and syringes as clinical sharps; the product is single-use and must not be resterilised or reused.
Contraindications
Use in patients under 21 years of age
Pregnancy or breastfeeding
Known hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or to any component of the formulation
History of severe or recurrent hypertrophic scarring or keloid formation
Active inflammatory or infectious skin disease (e.g., herpes, bacterial infection, dermatitis) at or near the intended injection site
Bleeding disorders or current use of thrombolytics, anticoagulants or strong antiplatelet agents that significantly increase bleeding risk (unless managed according to local protocols)
Previous hypersensitivity reactions to dermal fillers or local anaesthetics of the same class
Simultaneous use in areas recently treated with laser resurfacing, deep chemical peels or dermabrasion until complete healing has occurred
Intravascular injection or injection into highly vascular danger zones (absolute contraindication for intravascular use)
Injection into periorbital regions specifically contraindicated by the IFU for this product line (e.g., eyelids and under-eye dark circle area) unless explicitly allowed by updated manufacturer guidance
Injection into or directly over permanent implants or other implanted devices in the treatment area
Adverse Effects
Transient inflammatory reactions at the injection site such as redness, swelling, tenderness, pain or warmth, typically resolving within about 1–2 weeks
Bruising or haematoma at or near the injection site
Nodules, papules or localised induration (lumps) in the treated area
Temporary asymmetry, over- or under-correction of wrinkles or volume
Skin discolouration, pigmentation changes or erythema at the injection site
Hypersensitivity or allergic reactions, including immediate or delayed-onset responses
Infection at the injection site, including abscess formation in rare cases
Granuloma formation or foreign-body reactions, as reported with hyaluronic acid fillers in general
Vascular occlusion due to unintended intravascular injection, potentially leading to skin necrosis (including glabellar necrosis in the literature for HA fillers), visual disturbance or, in extremely rare cases, blindness
Systemic lidocaine-related adverse events in cases of overdose or high systemic exposure, such as central nervous system symptoms (e.g., dizziness, tinnitus, seizures) or cardiac conduction disturbances
Storage Conditions
Store between 1 °C and 30 °C.
Protect from direct sunlight and keep in the original packaging until use.
Do not freeze; avoid excessive heat and temperature fluctuations.
Keep dry and out of reach of unauthorised persons and children.
Do not use after the expiry date or if the blister or syringe packaging is damaged or opened.
Duration
Results are described as long-lasting for a hyaluronic acid dermal filler; in clinical practice effects typically persist for several months, depending on treatment area, injection technique, product volume and individual patient metabolism. The manufacturer does not state a precise duration in months for LAPIENA Classic.
Onset
Immediate visible correction during and immediately after injection, with final appearance stabilising over the following days as any procedure-related swelling subsides.
