Device Dossier

HArmonyCa® Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Device Dossier for HArmonyCa® Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic (Synthetic-fluid tissue reconstructive material,…

Intended purpose

HArmonyCa® Lidocaine is a dermal filler intended for facial soft tissue augmentation and should be injected into the deep dermal and sub-dermal layers. The lidocaine in the product is for reducing pain during treatment.

Functional description

HArmonyCa® Lidocaine is a sterile, apyrogenic, viscous, opaque, injectable, semi-solid, latex free and bio-degradable dermal implant. The implant is intended for sub-dermal and deep dermal use in specific facial regions. The product contains 0.3% (w/v) lidocaine HCl to reduce pain during treatment.

TGA Public Summary