Device Dossier
Lenisna - Dermal tissue reconstructive material, synthetic polymer
Device Dossier for Lenisna - Dermal tissue reconstructive material, synthetic polymer (Dermal tissue reconstructive material, synthetic polymer, Class…
- GMDN category: Dermal tissue reconstructive material, synthetic polymer
Intended purpose
Device is intended to be used for intradermal and subcutaneous implantation in the face to fill skin depressions as to restore and enhance soft tissue volume. It is recommended to be used for reconstructive purposes in the treatment for morphological asymmetry.
Functional description
Injectable PLA (Poly-D,L lactic Acid) Filler is a white solid which is lyophilized mixed with PLA(Poly-D,L lactic Acid) and HA(Sodium Hyaluronate). When used, it is suspended in sterilized distilled water and made into a gel state, which can be injected into a syringe. When injected into wrinkles on the face, PLA micro-particles temporarily improve wrinkles by being physically filled subcutaneously. HA is used as a carrier to help inject the micro-particles into the syringe.