DeviceClearance

Product code QCR— General, Plastic Surgery

MolecuLight i:X

Classification name
Wound Autofluorescence Imaging Device
Device class
Class 1
Regulation
21 CFR 878.4165
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.”

— U.S. Food and Drug Administration, device classification record for product code QCR under 21 CFR 878.4165, via openFDA

Market context for product code QCR

FDA has cleared 1 device under product code QCR, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QCR

Recent clearances under product code QCR

Data sourced from openFDA. This site is unofficial and independent of the FDA.