LAPIENA Classic 1ml x 1 Syringe
Lapiena
Dermal fillerCross-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
- 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
- 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
Cross-linked hyaluronic acid dermal filler with lidocaine for fine to moderate facial lines
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)
- Earlobe augmentation and contour refinement
- Lip contouring and subtle lip volumisation
- Marionette lines and other superficial to medium-depth facial wrinkles
Composition
- Cross-linked hyaluronic acid 20 mg/ml (sodium hyaluronate cross-linked with 1,4-butanediol diglycidyl ether)
- Lidocaine hydrochloride 3 mg/ml (0.3%)
- 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.
