Device Dossier

Stylage L Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for Stylage L Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

Stylage® L lidocaïne is an injectable hyaluronic acid gel, intended to fill in facial skin depression (i.e. treatment of nasolabial folds) by injection into the dermis, by a skilled legally qualified practitioner trained in techniques for injecting implants. Lidocaïne hydrochloride is designed to reduce pain from the injection.

Functional description

Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity, which incorporates a medicinal substance (Lidocaine Hydrochloride). When injected, the device generates volume by filling in the treatment area and is reabsorbed over time. The device is packed in a 1mL pre-filled syringe. The ancillary role of Lidocaine Hydrochloride is to reduce pain associated with injections into the skin.

TGA Public Summary