FDA product code QJF: Autofluorescence Imaging Adjunct Tool For Wounds
QJF is the FDA product code for autofluorescence imaging adjunct tool for wounds. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under QJF, 4 in the last five years, from 4 different applicants. The average 510(k) review took 173 days (median 196); 236 days on average over the last three years. FDA has posted 1 recall for QJF devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Autofluorescence Imaging Adjunct Tool For Wounds |
| Device class | Class II |
| Regulation | 21 CFR 878.4550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QJF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 196 |
| 2021 | 2 | 60 |
| 2022 | 1 | 160 |
| 2023 | 1 | 264 |
| 2025 | 1 | 202 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every QJF clearance
Top QJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| MolecuLight, Inc. | 4 | 2022-05-18 |
| Swift Medical, Inc. | 1 | 2026-02-24 |
| Kent Imaging, Inc. | 1 | 2025-03-26 |
| Precision Healing, LLC | 1 | 2023-12-05 |
Most recent QJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251678 | Swift Medical, Inc. | Swift Ray 1 | 2026-02-24 | 270 |
| K242669 | Kent Imaging, Inc. | SnapshotGLO (KB100) | 2025-03-26 | 202 |
| K230734 | Precision Healing, LLC | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | 2023-12-05 | 264 |
| K213840 | MolecuLight, Inc. | MolecuLight I:X | 2022-05-18 | 160 |
| K211901 | MolecuLight, Inc. | MolecuLightDX | 2021-07-21 | 30 |
Recalls for QJF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code QJF?
QJF is the FDA product code for autofluorescence imaging adjunct tool for wounds. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel.
What device class is QJF?
Class II, regulation 21 CFR 878.4550. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJF?
Across 7 cleared submissions the average was 173 days from receipt to decision (median 196).
Which companies have the most QJF clearances?
MolecuLight, Inc. (4); Swift Medical, Inc. (1); Kent Imaging, Inc. (1); Precision Healing, LLC (1).
Have QJF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code QJF
- Run a recall and safety report across every QJF manufacturer
- Watch product code QJF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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