Lapiena Deep Premium Cross-linked HA Dermal Filler with Lidocaine CE Marked

Recommended Injection Areas

  • Nasolabial Lines
  • Marionette Lines
  • Lip Volumizing
  • Glabella Lines
  • Forehead Lines

Lapiena dermal fillers, developed with advanced HCCL™ technology, ensure superior safety and stability. Using a patented low-temperature, extended cross-linking process, HCCL™ technology reduces BDDE levels and eliminates risks linked to residual BDDE, often seen as a foreign substance. This unique process creates a stable 3D matrix structure, allowing each Lapiena model to maintain optimal volume and shape, with rheological properties designed for long-lasting, natural results.

Clinical Validation and Patient Satisfaction

Clinical trials confirm that Lapiena dermal filler is both safe and effective for treating nasolabial folds, performing comparably to an FDA-approved reference product.

Testing Methodology
In a study involving 68 patients, independent evaluators used the Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) to assess results over a 24-week period following injection in the nasolabial fold area.

Safety and Patient Comfort
Clinical tests showed no significant safety concerns, confirming Lapiena as a reliable medical device. With added Lidocaine, Lapiena also provides pain relief during treatment, enhancing patient comfort and satisfaction.

Lapiena Product Information

HCCL Technology

The safety and effectiveness of Lapiena have been demonstrated in a comparative clinical trial.

Approved Ingredients

The Hyaluronic Acid used is of pharmaceutical grade and is approved with FDA DMF and EDQM certifications.

Proved Safety

A reinforced 3D matrix design that ensures maximum safety and achieves ideal rheological characteristics.

Safety Assessment

Lapiena has been evaluated as a safe medical device through clinical tests, which showed no clinically significant abnormalities.

Clinical Results

Our clinical trial verified that Lapiena is an effective and safe medical device for the correction of nasolabial fold and not inferior to the reference device*. (*The reference device is approved by US FDA)

Test Method

Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) were assessed with 68 patients by independent evaluators for 24 weeks after nasolabial fold injection.

CE Mark, ISO 13485

Lapiena is CE certified, indicating that the product meets the European Union's health, safety, and environmental standards for Class III medical devices.

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