Device Dossier

e.p.t.q. Lidocaine S500 - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for e.p.t.q. Lidocaine S500 - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

e.p.t.q. Lidocaine (S500) is intended to be used for the correction of nasolabial folds. The product is for cosmetic use only. The addition of lidocaine provides a pain-relieving effect during treatment.

Functional description

The device is a sterile, non-pyrogenic, viscoelastic, colourless, transparent gel composed of cross-linked sodium hyaluronate gel of non-animal origin. It is an injectable gel implant which incorporates 0.3% lidocaine hydrochloride (medicinal substance). The ancillary role of lidocaine hydrochloride is to reduce the pain associated with injections into the skin.

TGA Public Summary