Device Dossier
Stylage XL Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Device Dossier for Stylage XL Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…
- GMDN category: Synthetic-fluid tissue reconstructive material, anaesthetic
Intended purpose
Stylage® XL lidocaine is an injectable implant indicated for treatment of facial volumes (i.e. cheeks, cheekbones),restoration or augmentation by injection into the deep dermis or subcutaneously, by a skilled legally qualified practitioner trained in techniques for injecting implants. Lidocaine hydrochloride is designed to reduce pain from the injection.
Functional description
Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity. When injected into the deep dermis or subcutaneously in the treated area, the device generates volume and is slowly reabsorbed over time. The device is packed in a 1 ml pre-filled syringe. The ancillary role of Lidocaine Hydrochloride is to reduce pain associated with injections into the skin.