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LAPIENA DEEP 1ml x 1 Syringe

LAPIENA DEEP 1ml x 1 Syringe

Lapiena

Dermal filler
  • CE Marked medical device (CE 2265 for the product, CE 0068 for supplied needles as per the IFU).
  • Class III medical device classification in EU/EEA markets for cross Linked hyaluronic acid dermal fillers with lidocaine.
  • Manufactured under a quality management system compliant with ISO 13485 (referenced in distributor and manufacturer materials).
  • Hyaluronic acid raw material documented as pharmaceutical grade with FDA Drug Master File (DMF) and EDQM certification in manufacturer literature for the Lapiena line.
  • Sterilisation by moist heat for the gel and ethylene oxide for the needles, as indicated in the IFU.
  • Conforms to applicable European health, safety and environmental requirements for medical devices.
Cross-linked hyaluronic acid dermal filler with lidocaine for deep wrinkles and facial volume restoration

Description

LAPIENA DEEP is a CE-marked, cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, engineered using HCCL™ (High Cohesive Cross-Linked) technology. It offers enhanced viscoelastic properties and a reinforced 3D gel matrix, making it suitable for softening deep facial folds and restoring natural volume in areas subjected to frequent and repetitive movement. Supplied as a sterile, single-use pre-filled syringe (marketed as 1 ml but specified as 1.1 ml in the IFU), it is intended for injection into the medium to deep dermis or deep layer of the skin by trained medical professionals, delivering immediate, natural-looking and long-lasting correction of moderate to severe wrinkles and folds.

Bnefits

  • Enhanced viscoelastic properties designed for deep folds and volume restoration in dynamic facial areas.
  • Higher cohesivity and elasticity than the Classic variant for more pronounced volume enhancement and contouring.
  • Immediate visible results with little or no downtime for most patients.
  • Long-lasting effect compared with many non-cross-linked HA injectables, with distributor data indicating typical durations of around 12–18 months depending on area and patient.
  • HCCL™ technology uses a low-temperature, extended cross-linking process with reduced pendant BDDE, aiming to improve safety, stability and rheological performance.
  • Reinforced 3D gel matrix supports shape retention and natural facial movement.
  • Contains 0.3% lidocaine to reduce injection pain and improve patient comfort.
  • Clinical trial data support safety and effectiveness for nasolabial fold correction.
  • Pharmaceutical-grade hyaluronic acid, with raw material approvals including FDA DMF and EDQM (for the HA used in the Lapiena line).
  • Versatile: can be used alone or in combination with Lapiena Classic and Sub-Q for layered or full-face treatment strategies.

Indications

  • Correction of moderate to deep facial wrinkles and folds in adults over 21 years of age.
  • Filling fine and deep facial wrinkles and nasolabial folds.
  • Treatment of nasolabial lines (nasolabial folds).
  • Marionette lines around the mouth and lower face.
  • Lip volumising and enhancement of lip definition (lip volumizing).
  • Glabella (glabellar) lines, with care to avoid intravascular injection in high-risk zones.
  • Horizontal forehead lines.
  • Correction of age-related sagging of facial contours and restoration of facial volume in areas subjected to frequent movement (e.g. mid-face regions).
  • General correction of facial wrinkles and folds and lifting of facial soft tissues as per the Lapiena IFU.

Composition

  • Cross-linked hyaluronic acid 20 mg/ml (sodium hyaluronate cross-linked using 1,4-butanediol diglycidyl ether).
  • Lidocaine hydrochloride 3 mg/ml (0.3%).
  • Phosphate buffer saline solution with excipients, pH approximately 7, q.s. to full volume.
  • Sterile, pyrogen-free, highly viscous monophasic water-based gel.

Formulation

  • Sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid with 0.3% lidocaine, colourless and highly viscous.
  • Monophasic HA gel produced with HCCL™ technology for high cohesivity, elasticity and plasticity.
  • Intended for intradermal use: injected into the deep dermis or deep layer of the skin for deep wrinkles and folds.
  • Pre-filled single-use syringe (IFU: 1.1 ml nominal volume for the DEEP variant).

Packaging

  • 1 x 1.1 ml pre-filled syringe of LAPIENA DEEP gel (marketed by some distributors as 1 ml x 1 syringe).
  • 1 x 25G needle (sterile, single use).
  • 1 x 27G needle (sterile, single use).
  • Sterile blister packaging containing the syringe and needles.
  • Outer carton with product labelling, CE mark, batch number, expiry date and instructions for use.

Usage

  • LAPIENA DEEP is for use only by licensed and appropriately trained healthcare professionals experienced in dermal filler injections.
  • Take a full medical history and assess indications, contraindications and patient expectations prior to treatment.
  • Store the product as recommended; before injection, allow the syringe to reach room temperature (approximately 30 minutes).
  • Inspect the packaging and syringe; do not use if the blister, syringe or sterility barrier is damaged, opened or past the expiry date.
  • Prepare the treatment area by thoroughly disinfecting the skin; maintain strict aseptic technique throughout the procedure.
  • Attach a supplied sterile needle (25G or 27G) securely to the syringe and expel a small drop of gel to remove air before injection.
  • Inject slowly into the deep dermis or deep layer of the skin, using appropriate techniques such as linear threading or serial puncture; the injected volume depends on the depth and severity of the wrinkle or fold.
  • Avoid intravascular injection; if blanching or paleness of the skin occurs, stop injection immediately and gently massage until normal colour returns.
  • After injection, gently massage the treated area to ensure even distribution and integration with surrounding tissues, avoiding excessive pressure.
  • Do not over-correct at the first session; additional correction can be performed immediately or after a few weeks based on clinical assessment.
  • Avoid mixing the product with other injectable products in the same syringe or injection site.
  • Advise patients to avoid makeup for at least 12 hours post-treatment and to avoid strong sun/UV exposure, extreme heat or cold, saunas and vigorous exercise for approximately 2 weeks.
  • Used needles and syringes are single use only and must be disposed of in approved sharps containers; do not resterilise or reuse.

Contraindications

  • Use in individuals under 21 years of age.
  • Pregnant or breastfeeding women.
  • Known hypersensitivity to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or any component of the formulation.
  • Patients prone to hypertrophic scarring or keloid formation.
  • Injection into the periorbital area (under-eye dark circles and eyelids) as specified in the IFU.
  • Intravascular injection (into blood vessels) or injection into high-risk vascular zones where intravascular placement is more likely.
  • Injection into areas with active inflammatory or infectious skin disease (e.g. local infections, herpes outbreaks, dermatitis) at or near the intended injection site.
  • Concurrent use in areas recently treated with laser therapy, deep chemical peels or dermabrasion until the skin has fully healed.
  • Injection directly into or over areas with permanent implants or other foreign bodies in the treatment zone.
  • Use in patients with uncontrolled bleeding disorders or in those who have received thrombolytics, anticoagulants or platelet aggregation inhibitors within the preceding two weeks, unless managed according to local clinical protocols.
  • Patients with a known severe allergy to local anaesthetics of the amide type.

Adverse Effects

  • Common transient inflammatory reactions at the injection site, such as redness, swelling, pain, tenderness or warmth, typically resolving within up to 1–2 weeks.
  • Hematoma or bruising at or near the injection site.
  • Formation of nodules, papules or localised induration (lumps) in the treated area.
  • Temporary asymmetry, overcorrection or undercorrection of wrinkles or volume.
  • Skin discolouration or pigmentation changes at the injection site.
  • Unsatisfactory aesthetic result or insufficient filling effect.
  • Local infection at the injection site, potentially including abscess formation in rare cases.
  • Granuloma formation or foreign-body reactions, as reported with hyaluronic acid fillers more generally.
  • Immediate or delayed hypersensitivity reactions, including swelling, erythema or pruritus.
  • Serious but rare complications described in the HA filler literature, including glabella necrosis, skin necrosis due to vascular occlusion, and visual disturbances or blindness from inadvertent intravascular injection.
  • Systemic lidocaine-related adverse effects in the event of excessive systemic exposure, such as central nervous system symptoms (e.g. dizziness, tinnitus, seizures) or cardiac conduction abnormalities.

Storage Conditions

  • Store at 1–30 °C (as stated in the IFU).
  • Protect from direct sunlight and freezing.
  • Keep in the original packaging until use to maintain sterility and protect from light and moisture.
  • Keep dry and do not expose to excessive heat or temperature fluctuations.
  • Do not use if the packaging or sterility barrier is damaged or opened, or after the labelled expiry date.
  • Keep out of reach of children and unauthorised persons.

Duration

Distributor and reseller information for Lapiena Deep typically report results lasting around 12\u201318 months, depending on treatment area, injection technique, volume used and individual patient metabolism. The IFU itself describes the product as long-lasting without specifying an exact duration in months.

Onset

Immediate visible correction during and immediately after injection, with final appearance settling over the following days as transient procedure-related swelling and redness resolve.

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