Swift Ray 1
FDA 510(k) clearance K251678 · decided 2026-02-24
Clearance details
- K-number
- K251678
- Device name
- Swift Ray 1
- Applicant
- Swift Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-30
- Decision date
- 2026-02-24
- Days to decision
- 270 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
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| SnapshotGLO (KB100) (K242669) | Kent Imaging, Inc. | 2025-03-26 |
| Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (K230734) | Precision Healing, LLC | 2023-12-05 |
| MolecuLight I:X (K213840) | MolecuLight, Inc. | 2022-05-18 |
| MolecuLightDX (K211901) | MolecuLight, Inc. | 2021-07-21 |
| MolecuLight I:X (K210882) | MolecuLight, Inc. | 2021-06-22 |
| MolecuLight i:X (K191371) | MolecuLight, Inc. | 2019-12-04 |
Recalls involving this device
No recalls on record reference this clearance.