PR Newswire12.14.21
Klox Technologies Inc., provider of Fluorescent Light Energy (FLE)-based systems to treat diseases and conditions affecting the skin and soft tissues, announced the United States Food and Drug Administration (FDA) has granted the company De Novo clearance for the LumiHeal System. The LumiHeal System is the first FLE-based device cleared by the FDA and it is currently indicated to provide fluorescent and blue light to post-surgical incisions for scar management.
The LumiHeal System is a first-in-class, proprietary, non-invasive, non-thermal treatment that employs FLE for reducing the appearance and feel of acute post-surgical incisions.
"The FDA De Novo review process is designed to determine that the clinical benefits outweigh the clinical risks associated with a medical device when there is no substantially equivalent predicate device. It is a rigorous process, and we worked diligently with the FDA to achieve the landmark grant of our De Novo request for classification," stated Dr. Daniela Jukic, Senior Director, Regulatory Affairs, Compliance and Quality Assurance.
"We believe that the LumiHeal System can make a significant difference in the way we manage post-surgically incisions and opens the way to further indications for the U.S. market," stated Howard Walthall, CEO of Lumiheal Therapeutics Inc., Klox Technologies' U.S.-based partner located in Alabama.
The LumiHeal System is a first-in-class, proprietary, non-invasive, non-thermal treatment that employs FLE for reducing the appearance and feel of acute post-surgical incisions.
"The FDA De Novo review process is designed to determine that the clinical benefits outweigh the clinical risks associated with a medical device when there is no substantially equivalent predicate device. It is a rigorous process, and we worked diligently with the FDA to achieve the landmark grant of our De Novo request for classification," stated Dr. Daniela Jukic, Senior Director, Regulatory Affairs, Compliance and Quality Assurance.
"We believe that the LumiHeal System can make a significant difference in the way we manage post-surgically incisions and opens the way to further indications for the U.S. market," stated Howard Walthall, CEO of Lumiheal Therapeutics Inc., Klox Technologies' U.S.-based partner located in Alabama.