510(k) K251678
- Device
- Swift Ray 1
- Applicant
- Swift Medical, Inc.
- 510(k) number
- K251678
- Product code
- QJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-24
- Date received
- 2025-05-30
- Regulation
- 878.4550
- Classification name
- Autofluorescence Imaging Adjunct Tool For Wounds
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tenzin Yangzom
- Address
- 1 King St. W, Suit 4800-355 Toronto CA M5H 1A1 M5H 1A1
FDA Registration Numbers#
- 3001744314
- 3039395626
- 3009771004
- 3018781093
- 3041244757
- 3014704068
- 3013443304
Source Documents#
Other 510(k) Records For Product Code QJF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | 2025-03-26 |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Precision Healing, LLC | 2023-12-05 |
| K213840 | MolecuLight I:X | MolecuLight, Inc. | 2022-05-18 |
| K211901 | MolecuLightDX | MolecuLight, Inc. | 2021-07-21 |
| K210882 | MolecuLight I:X | MolecuLight, Inc. | 2021-06-22 |
| K191371 | MolecuLight i:X | MolecuLight, Inc. | 2019-12-04 |