QJF
- Product code
- QJF
- Device name
- Autofluorescence Imaging Adjunct Tool For Wounds
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4550
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251678 | 2026-02-24 | Swift Medical, Inc. | Swift Ray 1 | |
| K242669 | 2025-03-26 | Kent Imaging, Inc. | SnapshotGLO (KB100) | |
| K230734 | 2023-12-05 | Precision Healing, LLC | Multispectral Imager Kit (MSI Kit) (300-00015), Mult |
Official FDA classification page: QJF
Classification and pathway per current FDA publications. Data from openFDA (CC0).