K251678 is an FDA 510(k) clearance for the Swift Ray 1. This device is classified as a Autofluorescence Imaging Adjunct Tool For Wounds (Class II - Special Controls, product code QJF).
Submitted by Swift Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on February 24, 2026, 270 days after receiving the submission on May 30, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4550. 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) Number | K251678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | February 24, 2026 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QJF - Autofluorescence Imaging Adjunct Tool For Wounds |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4550 |
| 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. |