SnapshotGLO (KB100)
FDA 510(k) clearance K242669 · decided 2025-03-26
Clearance details
- K-number
- K242669
- Device name
- SnapshotGLO (KB100)
- Applicant
- Kent Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-05
- Decision date
- 2025-03-26
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- QJF
- Device class
- 2
- Regulation number
- 878.4550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Calgary, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. recall (Z-2775-2026) | KENT IMAGING, INC. | 2026-07-22 |