LUSEE™
Injectable Volumizing Implant
LUSEE™ injectable volumizing implant was developed with the latest achievements of modern aesthetic medicine. Our products gives patients opportunity to get a perfect look without surgery or long recovery time.
Lusee™, voumizing injectable implant for engoprosthetics of Human soft tissues are produced within the EU in compliance with established standards.:
EN ISO 13485:2012,
ISO 13485:2016 Medical devices - Quality Management system. EN ISO 10993 Biological evaluation of medical devices
EN 556-2:2015 Sterilization of medical devices
EN ISO 11607-1:2018 Packaging for terminally sterilized medical devices.
EN ISO 14630:2012 Non-active surgical implants – General requirements
MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies.
LUSEE™ manufacturied in EU facilities by ZAFIRA INVESTMENS LTD.
Medical device Lusee™, Sterile Hydrophilic Gel for endoprosthetics of human soft tissues is manufactured in accordance with the requirements for regulatory purposes that ensure that organizations involved in the design and production of medical devices consistently meet regulatory and customer requirements for safety and performance.
