Autofluorescence Imaging Adjunct Tool For Wounds
The Autofluorescence Imaging Adjunct Tool For Wounds is a Class 2 general surgery and dermatological device that uses autofluorescence technology to detect tissues or structures in wounds, functioning as an adjunct tool that is not intended to provide a definitive diagnosis. It requires 510(k) clearance and is regulated under 21 CFR 878.4550 within the General and Plastic Surgery medical specialty. The product code is QJF. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QJF
- Device Class
- FDA class 2
- Regulation Number
- 878.4550
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251678 | Swift Ray 1 | Feb 24, 2026 | Substantially Equivalent | Swift Medical, Inc. |
| K242669 | SnapshotGLO (KB100) | Mar 26, 2025 | Substantially Equivalent | Kent Imaging, Inc. |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Dec 05, 2023 | Substantially Equivalent | Precision Healing, LLC |
| K213840 | MolecuLight I:X | May 18, 2022 | Substantially Equivalent | MolecuLight, Inc. |
| K211901 | MolecuLightDX | Jul 21, 2021 | Substantially Equivalent | MolecuLight, Inc. |
| K210882 | MolecuLight I:X | Jun 22, 2021 | Substantially Equivalent | MolecuLight, Inc. |
| K191371 | MolecuLight i:X | Dec 04, 2019 | Substantially Equivalent | MolecuLight, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.