Autofluorescence Imaging Adjunct Tool For Wounds
General, Plastic Surgery · 21 CFR 878.4550
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 MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
8 firms currently registered for this product code
Exact Medical Manufacturing, Inc.
Changzhou Jiangsu, CN
Artaflex Buffalo Inc.
Buffalo, NY, US
Kent Imaging Inc
Calgary Alberta, CA
Moleculight Inc.
TORONTO Ontario, CA
Adiuvo Diagnostics Private Limited
Visakhapatnam Andhra Pradesh, IN
Exact Medical Manufacturing, Inc.
Changzhou Jiangsu, CN
Swift Medical
Toronto Ontario, CA
510(k) clearances
7 clearances for this product code
- Swift Medical, Inc.Feb 24, 2026
K251678 · Swift Ray 1
- Kent Imaging, Inc.Mar 26, 2025
K242669 · SnapshotGLO (KB100)
- Precision Healing, LLCDec 5, 2023
K230734 · Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
- MolecuLight, Inc.May 18, 2022
K213840 · MolecuLight I:X
- MolecuLight, Inc.Jul 21, 2021
K211901 · MolecuLightDX
- MolecuLight, Inc.Jun 22, 2021
K210882 · MolecuLight I:X
- MolecuLight, Inc.Dec 4, 2019
K191371 · MolecuLight i:X