FDA Product Code QJF: Autofluorescence Imaging Adjunct Tool For Wounds
An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Moleculight, Inc., Precision Healing, LLC and Kent Imaging, Inc..
FDA 510(k) Cleared Autofluorescence Imaging Adjunct Tool For Wounds Devices (Product Code QJF)
About Product Code QJF - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QJF since 2019, with 7 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QJF have taken an average of 236 days to reach a decision - up from 148 days historically. Manufacturers should account for longer review timelines in current project planning.
QJF devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →