www.fdanews.com/articles/205875-klox-technologies-fluorescent-light-lumiheal-system-gets-fdas-de-novo-clearance
Klox Technologies’ Fluorescent Light LumiHeal System Gets FDA’s De Novo Clearance
December 21, 2021
Klox Technologies has received the FDA’s de novo clearance for its LumiHeal System, a fluorescent light energy-based therapeutic system.
The approved indication of the LumiHeal System is to provide fluorescent and blue light therapy for postsurgical incisions for scar management, the Laval, Quebec, Canada-based company said.
The LumiHeal System is a noninvasive, nonthermal treatment that uses fluorescent light energy to reduce the appearance and feel of acute postsurgical incisions.