Device Dossier

saypha volume - Dermal tissue reconstructive material, microbe-derived

Device Dossier for saypha volume - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material, microbe-derived, Class…

Intended purpose

The intended aesthetic purpose of saypha volume is to add volume. It is indicated to correct moderate to severe nasolabial folds, and must be injected into the deep dermis or subcutis.

Functional description

A sterile, biodegradable, viscoelastic, clear, colourless, isotonic and homogenized injectable gel implant. The viscoelastic implant consists of highly cross-linked hyaluronic acid formulated to a concentration of 23 mg/ ml in a physiological buffer.

TGA Public Summary