QJF
7 FDA 510(k) clearances · Product code
196 daysmedian time to decision
270 days90th percentile
7clearances measured
FDA profile
- Official device name
- Autofluorescence Imaging Adjunct Tool For Wounds
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4550
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Swift Ray 1 (K251678) | Swift Medical, Inc. | 2026-02-24 |
| SnapshotGLO (KB100) (K242669) | Kent Imaging, Inc. | 2025-03-26 |
| Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (K230734) | Precision Healing, LLC | 2023-12-05 |
| MolecuLight I:X (K213840) | MolecuLight, Inc. | 2022-05-18 |
| MolecuLightDX (K211901) | MolecuLight, Inc. | 2021-07-21 |
| MolecuLight I:X (K210882) | MolecuLight, Inc. | 2021-06-22 |
| MolecuLight i:X (K191371) | MolecuLight, Inc. | 2019-12-04 |
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Every clearance here is in the API, with alerts when new ones post.