K242669 is an FDA 510(k) clearance for the SnapshotGLO (KB100), a Autofluorescence Imaging Adjunct Tool For Wounds (Class II — Special Controls, product code QJF), submitted by Kent Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on March 26, 2025, 202 days after receiving the submission on September 5, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4550.
| 510(k) Number | K242669 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2024 |
| Decision Date | March 26, 2025 |
| Days to Decision | 202 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. |