QJF — Autofluorescence Imaging Adjunct Tool For Wounds Class II

FDA Device Classification

Classification Details

Product Code
QJF
Device Class
Class II
Regulation Number
878.4550
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251678swift medicalSwift Ray 1February 24, 2026
K242669kent imagingSnapshotGLO (KB100)March 26, 2025
K230734precision healingMultispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-December 5, 2023
K213840moleculightMolecuLight I:XMay 18, 2022
K211901moleculightMolecuLightDXJuly 21, 2021
K210882moleculightMolecuLight I:XJune 22, 2021
K191371moleculightMolecuLight i:XDecember 4, 2019