MolecuLight I:X
FDA 510(k) clearance K213840 · decided 2022-05-18
Clearance details
- K-number
- K213840
- Device name
- MolecuLight I:X
- Applicant
- MolecuLight, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-09
- Decision date
- 2022-05-18
- Days to decision
- 160 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Swift Ray 1 (K251678) | Swift Medical, Inc. | 2026-02-24 |
| 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 |
| 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.