Autofluorescence Imaging Adjunct Tool For Wounds
FDA product code QJF · Class II (moderate risk) · 21 CFR 878.4550 · General, Plastic Surgery
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.
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251678 | Swift Ray 1QJF · Traditional | Swift Medical, Inc. | 02/24/2026SE |
| K242669 | SnapshotGLO (KB100)QJF · Traditional | Kent Imaging, Inc. | 03/26/2025SE |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)QJF · Traditional | Precision Healing, LLC | 12/05/2023SE |
| K213840 | MolecuLight I:XQJF · Traditional | MolecuLight, Inc. | 05/18/2022SE |
| K211901 | MolecuLightDXQJF · Special | MolecuLight, Inc. | 07/21/2021SE |
| K210882 | MolecuLight I:XQJF · Traditional | MolecuLight, Inc. | 06/22/2021SE |
| K191371 | MolecuLight i:XQJF · Traditional | MolecuLight, Inc. | 12/04/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2775-2026 Class II | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.The software controlling the wound imaging device's battery charging circuit was not designed to recognize… | Kent Imaging, Inc. | 06/30/2026Open, Classified |