ASIROX - EVOLVE
Medical-aesthetic diode laser hair-removal platform for all skin phototypes.
ASIROX-EVOLVE is a medical-aesthetic diode laser hair-removal platform developed to deliver effective, safe and long-lasting results on all skin phototypes.
Building on the ASIROX - INITIA device, MeDev Consulting carried out the development, industrialization and CE MD marking of the ASIROX-EVOLVE medical device.
The development included a hair-removal laser diode with a fast multi-applicator system, plus EMC, electrical safety, functionality and usability certificates.
MeDev Consulting managed and implemented an ISO 13485-based quality system for Diagonal Medical Esthetic.
It also took part in obtaining the AEMPS manufacturing license and the market-placement notification in the CPS registry.
Class IIb medical device, NB 0476 KIWA.