FDA Grants Device Designation Status for Klox’s LumiHeal System
LAVAL, Quebec, DECEMBER 12, 2019 -- Klox Technologies Inc. (‘Klox’) a regenerative medicine company developing and commercializing its proprietary fluorescent light energy generating platform within dermatology, wound care, and animal health, today announced, following remitting a Request for Designation, that the US Food & Drug Administration’s Office of Combination Products has given the LumiHeal System Device designation and will be reviewed and regulated by the Center for Devices and Radiological Health (CDRH).“This exciting milestone paves the way for Klox to address the single largest