DeviceClearance

Product code QJF— General, Plastic Surgery

MolecuLight I:X

Classification name
Autofluorescence Imaging Adjunct Tool For Wounds
Device class
Class 2
Regulation
21 CFR 878.4550
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QJF under 21 CFR 878.4550, via openFDA

Market context for product code QJF

FDA has cleared 7 devices under product code QJF between 2019 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJF

Recent clearances under product code QJF

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